[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"quality-of-lifte\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:quality-of-lifte":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,83,114,145,174,205],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100634401","precarity-and-reduction-of-its-impact-on-the-mental-health-of-health-students-100634401",false,"NCT07539207","Precarity and Reduction of Its Impact on the Mental Health of Health Students","PRISMES","Inclusion Criteria:\n\n* Enrollment as a health student at the Faculty of Health, Université de Rouen Normandie (any program or discipline).\n\nAge between 18 and 30 years.\n\nMeet at least one of the following three financial vulnerability criteria:\n\nInsufficient monthly funds to cover basic living expenses. Recurrent monthly bank overdraft. Frequent omission of food purchases due to financial constraints. Affiliation with a social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded:\n\nCurrently receiving, or having received in the past 12 months, psychological or sophrology follow-up.\n\nCurrently treated for, or having been treated in the past 12 months for, anxiety or depression.",true,"ALL","18 Years","30 Years",{"count":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"NA","Student financial insecurity has become a major public health and societal issue affecting a growing proportion of young adults in higher education, exacerbated by the COVID-19 pandemic and more recently by inflation. Health students may be particularly exposed because of the demanding and lengthy nature of their training, often combined with limited opportunities for paid work due to hospital placements and academic workload. A national study conducted in 2024 by the Unit Institut national de la santé et de la recherche médicale U1073 under the supervision of the Conférence Nationale des Doyens de Médecine among more than 12,000 health students showed that 12% experienced severe financial insecurity, characterized by insufficient monthly resources, recurrent bank overdrafts, and frequent food deprivation, while 20% reported moderate insecurity. Financial insecurity was strongly associated with anxiety, depression, and emotional exhaustion, while vulnerable students were also more likely to forgo healthcare, including psychological consultations, for financial reasons. This vicious circle between financial hardship and mental health may compromise academic success and justifies targeted intervention.\n\nAlthough support systems such as Santé Psy Étudiant and free psychological consultations at the faculty already exist, they remain underused because of stigma, insufficient information, or perceived barriers to access. The PRISMES project proposes a participatory, adaptive, and real-world intervention designed to improve mental health support for financially vulnerable health students.\n\nStudents directly participate in the co-construction of interventions together with researchers, student associations, health professionals, academic representatives, and a sociologist involved in understanding social determinants, mental health representations, and barriers to participation. Three intervention formats will initially be proposed, Three types of interventions are offered to students. Intervention I consists of four individual psychological consultations. Intervention II includes two collective workshops focused on stress and budget management, combined with two sophrology sessions. Intervention III comprises one psychological consultation and two collective workshops on stress and budget management.. This non-randomized design reflects real-life implementation conditions and improves future transferability.\n\nThe main objective is to provide concrete support to financially vulnerable students by improving well-being, mental health, and knowledge of available support systems. Secondary objectives are to evaluate intervention effects on anxiety, depression, stress, quality of life, and emotional exhaustion, to adapt interventions according to feedback, and to improve awareness and use of social and health support services.\n\nA mixed-method design will combine quantitative and qualitative data. Quantitative assessments will be conducted monthly during the three months following the first intervention and again three months after the final intervention. Validated questionnaires will assess perceived stress (Cohen scale), anxiety and depression (HAD score), quality of life, and emotional exhaustion (MBI-SS). Qualitative interviews and focus groups conducted at the end of the intervention will explore perceived benefits, barriers, and implementation factors among students and professionals.\n\nThe adaptive design allows continuous adjustment according to interim findings. For example, if attendance is limited by timetable constraints, sessions may be rescheduled. Feedback loops involving participants and stakeholders will guide iterative improvement.\n\nEligible participants are health students aged 18-30 enrolled at Université de Rouen Normandie presenting at least one indicator of financial insecurity: insufficient monthly resources, recurrent overdraft, or frequent food deprivation. Students currently receiving psychological follow-up are excluded.\n\nAssuming a reduction in anxiety prevalence from 55% to 45%, 88 participants are required; with 20% loss to follow-up, 110 students will be included. Among approximately 4,500 health students in Rouen, about 540 are estimated to experience severe insecurity and 900 moderate insecurity, ensuring strong feasibility. PRISMES aims to generate directly transferable recommendations for university support policies and improve resilience, well-being, and academic success.",[28,29,30],"Mental Health (Depression)","Mental Health","Quality of Lifte",[32,33,34],"university student","economic precarity","mental health","NOT_YET_RECRUITING","2026-06-09",{"date":38,"type":39},"2026-06-11","ACTUAL",{"date":41,"type":22},"2026-09-15",{"date":43,"type":22},"2027-09-30",{"name":45,"class":46},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100489612","ifd-survive-functional-efficacy-and-biological-correlates-reconcile-study-100489612","NCT05655390","iFD-SuRvivE funCtiONal effiCacy and bIologicaL corrElates (RECONCILE Study)","The SURVIVE 2 Project: An Extended Cohort Study to Investigate Suicidal Behavior in Spain and the Efficacy of Secondary Prevention Strategies: iFD-SuRvivE funCtiONal effiCacy and bIologicaL corrElates (RECONCILE Study)","RECONCILE","Inclusion Criteria:\n\n* Age over 18 years old\n* Having attempted suicide\n* Provide written informed consent\n* No claustrophobia\u002Fmetallic objects\u002Fimplants\n\nExclusion Criteria:\n\n* Intelligence quotient below 70 and impaired functioning\n* Any medical condition that could affect neuropsychological performance (such as neurological diseases) or a history of head trauma with loss of consciousness\n* Participation in any structured psychological intervention within the past 6 months\n* Patients who received electroconvulsive therapy within the past 6 months\n* Inability to give inform consent",{"count":57,"type":22},120,[25],"The goal of this clinical trial is to assess the effectiveness of an original intervention 'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program' (from the original Spanish version: Programa Grupal De Recuperación Funcional En Depresión Y Prevención De Riesgo Suicida Basado En Regulación Emocional Y Valores) in depressed patients who have recently attempted suicide by improving their psychosocial functioning and therefore enhancing their ability to perform activities of daily living. As secondary objectives, the effectiveness of the intervention will be evaluated by determining cognitive performance (particularly decision-making, inhibition, and attention), quality of life, clinical status, and their relationship with neuroimaging correlates. Main target neuroimaging areas include the orbitofrontal cortex and dorsal prefrontal cortex.",[61,62,63,64,30],"Suicide, Attempted","Functioning, Psychosocial","Cognition","Neuroimaging",[66,67,68,69,70],"suicide","cognition","neuroimaging","psychosocial functioning","quality of life","RECRUITING","2026-05-08",{"date":74,"type":39},"2026-05-12",{"date":76,"type":39},"2025-09-16",{"date":78,"type":22},"2027-10",{"name":80,"class":81},"Iria Grande","OTHER",4,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":47},"100589569","electrical-vestibular-nerve-stimulation-vens-as-a-treatment-for-improving-sleep-in-visually-impaired-patients-100589569","NCT06956118","Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients","Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients With Visual Impairment","Inclusion Criteria:\n\n1. Signed Informed Consent\n2. Male or female, age ≥ 20 years and ≤ 60 years at the time of signing informed consent\n3. PSQI score ≥ 5 at screening and baseline\n4. Symptoms of sleep disorder lasting ≥ 3 months at the time of screening\n5. Severely Sight Impaired (defined as a visual acuity of \\\u003C 6\u002F60 but ≥3\u002F60 at 6 meters) OR blind (defined as a visual acuity of \\\u003C3\u002F60 at 6 metres).\n6. Participants must be accompanied by a family member or carer during the enrollment and initial study visit. For subsequent visits, accompaniment is encouraged; if a companion is unavailable, assistance will be provided by study staff or trained personnel.\n7. Can speak\u002Fread Hindi or English\n8. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device per the study protocol\n9. Ability and willingness to attend the clinic for 30-minute stimulation sessions 5 days per week for the duration of the treatment period (4-weeks).\n10. Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes\n11. Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial and haven't for 4 weeks before the trial\n12. Agreement not to use sleep trackers for the duration of the study (e.g. sleep app smart watches such as Fitbits)\n13. Agree not to travel across multiple time-zones during the duration of the study\n14. Agree to maintain a familiar sleeping environment\u002Froutine throughout the study and will not discontinue or begin treatment with new devices, used while sleeping, during the study (e.g. CPAP machines)\n\n    \\-\n\nExclusion Criteria:\n\n1. A PSQI score \\\u003C 5 at screening\n2. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.\n3. Previous diagnosis of a chronic viral infection, for example hepatitis or HIV\n4. A history of stroke or severe head injury requiring intensive care or neurosurgery\n5. Diagnosis of a current psychotic disorder\n6. Suffering from a current characterized depressive episode\n7. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).\n8. Pregnancy or breast-feeding or intends to become pregnant\n9. History of epilepsy\n10. History of active migraines with aura\n11. History of head injury requiring intensive care or neurosurgery\n12. History of diagnosed cognitive impairment such as Alzheimer's disease\u002Fdementia\n13. History of bipolar, psychotic or substance use disorders\n14. Regular use (more than twice a month) of antihistamine medication within the last 6 month. The subject can opt to switch to Fexofenadine (non-drowsy) and may enroll after a wash-out period of 2 weeks.\n15. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)\n16. A diagnosis of myelofibrosis or a myelodysplastic syndrome.\n17. Previous use of any VeNS device\n18. Participation in other clinical trials sponsored by Neurovalens or other insomnia studies\n19. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.\n20. History of vestibular dysfunction or other inner ear disease\n21. Member of the same household is currently or has previously participated in clinical study sponsored by Neurovalens\n\n    \\-","80 Years",{"count":92,"type":22},60,[25],"Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients with Visual Impairment.\n\nThis pilot clinical trial is testing whether a device called VeNS (vestibular nerve stimulation) can safely and effectively improve sleep in adults who are visually impaired.\n\nThe study will compare the active VeNS device to a sham (inactive) device. Participants will use the device under supervision for 30 minutes a day over 4 weeks, followed by a 4-week observation period. Researchers will assess sleep improvements, safety, and how acceptable and easy the treatment is for participants.\n\nAllocation: Randomized to either active device or control device usage.\n\nEndpoint classification: Efficacy Study\n\nIntervention Model: Parallel Assignment in 1:1 active to control allocation\n\nSample size: The aim is to recruit a total of up to 60 participants. The study will last 8 weeks in total for each subject.",[96,30,97],"Sleep Quality","Non-24 Sleep-Wake Disorder",[99,100,101,97,70,102,103],"sleep","sleep quality","insomnia","vestibular stimulation","neurostimulation","2026-04-13",{"date":106,"type":39},"2026-04-16",{"date":108,"type":39},"2025-12-01",{"date":110,"type":22},"2026-06",{"name":112,"class":113},"Neurovalens Ltd.","INDUSTRY",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":142,"locationsCount":144},"100620017","undiluted-and-diluted-nutrition-100620017","NCT07352150","Undiluted and Diluted Nutrition","The Influence of Diluted and Undiluted Enteral Nutrition on Nutritional Tolerance in Critically Ill Patients After Gastrointestinal Surgery - a Randomized Controlled Trial","Inclusion Criteria:\n\nAdults, ≥18, Scheduled for major abdominal surgery requiring ICU admission Having access to the GI tract (gastric or jejunal) Planned to be fed enterally\n\nExclusion Criteria:\n\nPatients unable to give informed consent After emergency surgeries Without access to the GI tract Individuals with contraindications to EN, such as short bowel syndrome, uncompensated shock, acidosis (pH \\\u003C 7.1; lactate \\> 5 mmol\u002Fl), bleeding from the upper GI tract, obstruction, intestinal ischemia, abdominal compartment syndrome Patients with symptomatic gastro-esophageal reflux Expected ICU stay \\\u003C 3 days Pregnancy and lactation",{"count":122,"type":22},80,[25],"Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial. Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN. The primary aim of this study is to assess feeding intolerance in both patient groups.",[126,127,128,129,30],"Critical Illness","Gastro Intestinal Surgery","Enteral Feeding Intolerance","Gastro-Intestinal Disorder",[131,132,133,134,135],"Zonulin","Intestinal fatty-acid binding protein (I-FABP)","Ketones","enteral feeding","GNAK","2026-01-11",{"date":138,"type":39},"2026-01-20",{"date":140,"type":22},"2026-02-02",{"date":43,"type":22},{"name":143,"class":81},"John Paul II Catholic University of Lublin",2,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":160,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":47},"100575487","effects-of-a-pulmonary-and-cardiovascular-rehabilitation-program-100575487","NCT06772922","Effects of a Pulmonary and Cardiovascular Rehabilitation Program","Inclusion Criteria:\n\n* Candidates for the pulmonary rehabilitation program: users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease.\n* Candidates for the cardiovascular rehabilitation program: users diagnosed with acute myocardial infarction, myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation.\n* Referral with medical clearance for rehabilitation\n\nExclusion Criteria:\n\n* Patients with any contraindication to aerobic or muscle-strengthening physical exercise, such as significant arrhythmias, untreated heart disease, myocarditis, recent or untreated pulmonary embolism, and uncontrolled systemic arterial hypertension, among other conditions.",{"count":152,"type":22},26,[25],"Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and improving functional capacity in patients with chronic respiratory conditions. The objective of this study is to evaluate the effects of the pulmonary and cardiovascular rehabilitation program on users of the physical therapy service of CECOM of UNICAMP related to functional capacity, quality of life and respiratory variables after 3 months of the program. Candidates for the pulmonary rehabilitation program are users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. Candidates for the cardiovascular rehabilitation program are users diagnosed with: infarction (AMI), myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. They should be referred to physical therapy by the cardiologist with complementary exams and exercise test. The program's assessment will consist of: anamnesis, analysis and recording of complementary exams, physical assessment (weight, height, BMI, cardiac and pulmonary auscultation, blood pressure, heart rate, peripheral oxygen saturation, respiratory muscle strength), functional capacity (six-minute walk test) and quality of life (questionnaire). The program will include aerobic exercises on a treadmill or stationary bike with an intensity between 50-70% of the reserve HR, below the ischemic thresholds. It will also include peripheral muscle strength exercises for the upper and lower limbs, in addition to respiratory muscle training for lung disease patients.",[156,30,157,158,159],"Respiratory Muscle Weakness","Dyspnea; Asthmatic","Dyspnea; Cardiac","Dyspnea",[161,162,163,164],"pulmonary rehabilitation","Non-communicable chronic diseases","cardiovascular disease","cardiac rehabilitation","2025-01-11",{"date":167,"type":39},"2025-01-14",{"date":169,"type":39},"2019-03-03",{"date":171,"type":22},"2025-12-20",{"name":173,"class":81},"University of Campinas, Brazil",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":182,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":47},"100569732","impact-of-equine-assisted-therapy-on-the-quality-of-life-of-children-with-autism-spectrum-disorders-asd-100569732","NCT06698068","Impact of Equine-Assisted Therapy on the Quality of Life of Children with Autism Spectrum Disorders (ASD)","Impact of Equine-Assisted Therapy on the Quality of Life of Children with Autism Spectrum Disorders (ASD): a Pilot Study","EQUI-TSA","Inclusion Criteria:\n\n* Children aged between 8 and 12 years.\n* Diagnosed with ASD by a doctor.\n* Able to participate in equine therapy sessions.\n* Capable of understanding instructions during equine therapy sessions.\n* Affiliated with the social security system.\n\nExclusion Criteria:\n\n* Children with ASD associated with ADHD (Attention Deficit Hyperactivity Disorder) and\u002For ODD (Oppositional Defiant Disorder) and\u002For ID (Intellectual Developmental Disorder) and\u002For DLD (Developmental Language Disorder) with comprehension impairments.\n* Ongoing equine-assisted therapy interventions.\n* Other severe medical conditions that may impair participation in sessions.\n* Allergies to horses.","8 Years","12 Years",{"count":185,"type":22},20,[25],"The main objective of this research is to measure the influence of equine-assisted therapy sessions on the quality of life of children with ASD, using the PedsQL™ 4.0 questionnaire as an evaluation tool.\n\nThe secondary objectives of this study are to measure the influence of these equine therapy sessions on the quality of life of parents of children with ASD, using the PAR-DD-QOL questionnaire, and to qualitatively analyze the progress of children in terms of communication, motor skills, social connections, etc., during equine therapy sessions, through tracking sheets.\n\nThis interventional, prospective, and monocentric study aims to evaluate the effect of equine therapy on the quality of life of children with ASD and their families. As a pilot study, it aims to assess the feasibility of a larger-scale study with a rigorous methodology, with the aim of including a control group and conducting a randomized, multicentric, single-blind trial in future studies. It will take place at the La Musse Hospital - La Renaissance Sanitaire, specifically within the equine therapy center of the La Musse facilities. Recruiting 20 children (8-12 years old) with ASD is required for this study. To do this, the inclusion criteria are as follows: participants must be children aged 8 to 12, diagnosed with ASD by a doctor. They must be able to participate in equine-assisted therapy sessions and understand instructions during these sessions. In addition, they must be affiliated with the social security system. The primary and secondary assessment criteria respectively include the average of the two scores obtained from the PedsQL™ 4.0 child and parent report questionnaires; the overall score of the PAR-DD-QOL questionnaire, as well as the qualitative analysis of the equine therapists' tracking sheets. Measures are taken to minimize selection, recruitment, and confusion biases, and specific eligibility criteria are defined. Each participant will benefit from 15 equine therapy sessions, twice a week, over 7 to 8 weeks. Each session will last 60 minutes.\n\nThe intervention of this study begins with the participant selection process, including an initial contact by phone or during a medical consultation, followed by an oral explanation and the provision of written information to parents and the child. After a reflection period, and if they agree, the parents and the child sign a consent form. The children then undergo 15 equine therapy sessions, including various activities such as emotional expression, contact with the horse, grooming, activities on foot or on horseback, and a debriefing time. Quality-of-life evaluations will be conducted five times during the study using the PedsQL™ 4.0 child, PedsQL™ 4.0 parent report, and PAR-DD-QOL questionnaires (before the first session, after the first session, at the 5th session, at the 10th session, and at the 15th session). Additionally, a tracking sheet will be completed by equine therapists during the sessions. The criteria for interrupting or modifying interventions are established, allowing participants to withdraw at any time for various reasons. Strategies are implemented to improve adherence to rehabilitation protocols, such as regular reminders and the distribution of a schedule of appointments. The individuals concerned are fully informed of the study and their rights.\n\nThe expected outcomes include an improvement in the average quality-of-life scores of children with ASD, an improvement in the quality-of-life score of their parents, and behavioral progress in the children. The sample size is set at 20 children with ASD, with a detailed statistical analysis plan using Excel and SPSS.",[189,190,191,30],"Equine-assisted Therapy","Children","Autism Spectrum Disorder",[193,194,195],"Equine-assisted therapy","children with ASD","Quality of life","2024-11-18",{"date":198,"type":39},"2024-11-20",{"date":200,"type":39},"2024-09-12",{"date":202,"type":22},"2025-11-30",{"name":204,"class":81},"Hopital La Musse",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":214,"studyType":215,"phases":4,"briefSummary":216,"conditions":217,"keywords":222,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":4},"100560951","incidence-and-complications-of-post-extubation-and-post-tracheostomy-dysphagia-in-adult-patients-in-the-critical-care-unit-100560951","NCT06583824","Incidence and Complications of Post-extubation and Post-tracheostomy Dysphagia in Adult Patients in the Critical Care Unit","Incidence and Complications Associated with Acquired Swallowing Disorder in the Intensive Care Unit in Extubated or Tracheotomized Patients: a Cohort Study","Inclusion Criteria:\n\nPatients aged ≥ 18 years, requiring intubation for ≥ 48 hours and\u002For subsequent tracheostomy, with an adequate level of consciousness to perform the dysphagia diagnostic test, and who have signed the consent form.\n\nExclusion Criteria:\n\nPrevious tracheostomy, prior diagnosis of dysphagia, neurodegenerative disease, or a history of stroke (CVA).",{"count":213,"type":22},414,"6 Months","OBSERVATIONAL","Acquired Swallowing Disorder in ICU (ICU-ASD), also known as postextubation dysphagia, is a multicausal problem experienced by survivors in intensive care units (ICUs) when the efficiency, safety of swallowing, or both are compromised. These alterations can lead to an increased risk of aspiration, respiratory complications, and malnutrition, potentially resulting in prolonged hospitalization, reduced quality of life, poorer clinical outcomes, and even death.\n\nDespite the clinical and social significance of this disorder, there is limited research addressing it. Existing studies primarily focus on incidence and associated factors, with scant attention to the occurrence of complications, and there is a lack of assessment of the quality of life of these patients. In our context, healthcare professionals are increasingly recognizing the importance of this issue, although the real incidence of ICU-ASD, as well as the frequency of respiratory and nutritional complications, remains unknown. Furthermore, the quality of life of patients with this disorder has not been evaluated thus far.\n\nObjectives:Primary: To analyze the occurrence of respiratory and nutritional complications associated with ICU-ASD in patients intubated for ≥48 hours or tracheotomized in the Intensive Care Unit of the University Hospital Complex of Albacete (ICU CHUA) and identify potential factors related to their occurrence.\n\nSpecific: To determine the incidence of ICU-ASD in the polyvalent ICU CHUA, assess the frequency of respiratory complications, evaluate nutritional status, assess quality of life, and determine the mortality of study participants.\n\nMaterial and Method: Prospective observational cohort study. Setting: Polyvalent ICU CHUA. Participants: Intubated patients for ≥48 hours or tracheotomized, with signed consent. Sampling: Consecutive. Sample size: 414 participants. Demographic\u002Fclinical variables. Outcome variables: Occurrence of respiratory complications, nutritional status, quality of life. Instruments: Modified Volume-Viscosity Swallowing Test (mV-VST), Swallowing Quality of Life Questionnaire (SWAL-QoL). Dysphagia detection will occur 24 hours post-extubation and\u002For 4 days after tracheotomy. Follow-up during hospitalization and post-ICU discharge until the outpatient consultation. Statistical analysis: Absolute and relative frequencies, measures of central tendency and dispersion, significance level of p \\< 0.05, 95% CI; Bivariate analysis: Checking group homogeneity and hypothesis testing: Chi-square, Student\\'s t-test, U-Mann-Whitney, ANOVA, or Kruskal-Wallis.",[218,219,30,220,221],"Respiratory Complications","Pneumonia","Death","Swallowing Disorder.Other Specified",[223,224,225,226,227,228,229],"dysphagia","tracheostomy","aspiration","malnutrition","critical care","mechanical ventilation","pneumonia","2024-09-03",{"date":232,"type":39},"2024-09-04",{"date":234,"type":22},"2024-09-10",{"date":236,"type":22},"2026-09-30",{"name":238,"class":81},"Complejo Hospitalario Universitario de Albacete"]