[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-fragmentation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-fragmentation":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,68,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100335345","improving-sleep-quality-during-pregnancy-using-an-oral-appliance-100335345",false,"NCT03646214","Improving Sleep Quality During Pregnancy Using an Oral Appliance","Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial","PREGNCCT","Inclusion Criteria:\n\n* Pregnant adults who snore\n* At least 8 teeth per arch\n* Mallampati score from I to II\n* Palatine tonsils grade 0,1 or 2\n* Capable of giving verbal and written informed consent\n* Able to apply the sleep recorder and the oral appliance.\n\nExclusion Criteria:\n\n* Pregnant \\> 32 weeks\n* Uncontrolled serious health issues\n* Cardiovascular or cardiac rhythm disorders\n* Pharmacological dependency\n* Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol\n* Ongoing temporomandibular joint disorders\n* Loose teeth or periodontal disease\n* History of uvulopalatopharyngoplasty (UPPP)",true,"FEMALE","18 Years","45 Years",{"count":22,"type":23},20,"ESTIMATED","INTERVENTIONAL",[26],"NA","Many pregnant women suffer from poor sleep quality and snoring. Evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. Snoring is a variant of obstructive sleep apnea (OSA) and OSA during pregnancy is associated with higher risks for cesarean delivery, gestational hypertension, preeclampsia and preterm delivery. It may also impact fetal outcomes negatively. The purpose of this study is to determine whether sleep quality can be improved in pregnant women who snore by means of an oral appliance that opens the airway. Sleep quality is evaluated objectively using an un-intrusive home sleep test system.",[29,30],"Snoring","Sleep Fragmentation","RECRUITING","2025-10-01",{"date":34,"type":35},"2025-10-07","ACTUAL",{"date":37,"type":35},"2018-02-01",{"date":39,"type":23},"2026-07-30",{"name":41,"class":42},"Texas A&M University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100444636","adaptive-neurostimulation-to-restore-sleep-in-parkinsons-disease-aim-2-100444636","NCT05070013","Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)","Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease: An Investigation of STN LFP Biomarkers in Sleep Dysregulation and Repair","Inclusion Criteria:\n\n* Signed informed consent\n* Diagnosis of Idiopathic Parkinson's disease (PD) with motor symptoms present for a minimum of 4 years\n* Severe motor symptoms (e.g., motor fluctuations, dyskinesia, tremor, bradykinesia, rigidity) despite optimized medical therapy, that warrant surgical implantation of deep brain stimulation (DBS), according to standard clinical criteria\n* Unified Parkinson's Disease Rating Scale (UPDRS-III) score off medication 20 to 80, and improvement of at least 30% in UPDRS-III score on medications, or tremor-dominant PD (score \\>\u002F= 2 on UPDRS-III tremor sub-score) or tremor in addition to other motor symptoms that are treatment-resistant and result in significant functional disability\n* Appropriate trials of oral PD medications resulting in inadequate relief of motor symptoms as determined by a movement disorders neurologist, and stable dose of anti-PD medications for 30 days prior to study enrollment\n* Requested and approved for subthalamic nucleus deep brain stimulation surgery (STN DBS) by study site Multi-Disciplinary Movement Disorders Patient Care Conference\n* Absence of abnormalities on brain magnetic resonance imaging (MRI) scan suggestive of an alternate diagnosis or serving as a contraindication to surgery\n* Absence of significant cognitive deficits or significant depression (Beck Depression Inventory-II, BDI-II, score \\> 20) on formal Neuropsychological Testing\n* Age 18 to 80 years (19 to 80 years in Nebraska)\n* Able to conduct follow up neurological care exclusively at study site for duration of the RC+S INS neurostimulator device lifespan (9 years)\n\nExclusion Criteria:\n\n* Any medical condition considered to elevate risk for surgical complications, such as coagulopathy,, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia, or anticoagulant medications that cannot be safely discontinued for perioperative period\n* Pregnancy (women of child-bearing potential must have a negative urine pregnancy test prior to surgical procedures)\n* Significant untreated depression (Beck Depression Inventory-II, BDI-II \\> 20 or Geriatric Depression Scale, GDS, score \\> 8)\n* Personality or mood disorder symptoms that investigators believe will interfere with study requirements\n* Required ongoing treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or diathermy\n* Pre-existing implanted stimulation system (e.g., cochlear implant, cardiac pacemaker, defibrillator, neuro-stimulator for indication other than Parkinson's disease), or ferromagnetic metallic implant\n* Prior intracranial surgery\n* History or active, drug or alcohol abuse\n* Meets criteria for Parkinson's disease (PD) with Mild Cognitive Impairment (PD-MCI), as defined by Performance \\> 2 standard deviations below appropriate norms on tests from 2 or more of the following cognitive domains: Attention, Executive Function, Language, Memory, and Visuospatial Ability\n* Restless Leg Syndrome\n* Obstructive Sleep Apnea\n* Inability to perform the recharge process necessary to use the RC+S brain stimulation system","ALL","80 Years",{"count":22,"type":23},[26],"Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood.\n\nThis study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.",[57,30],"Parkinson's Disease","2025-07-18",{"date":60,"type":35},"2025-07-22",{"date":62,"type":35},"2021-11-18",{"date":64,"type":23},"2026-06-30",{"name":66,"class":42},"University of Nebraska",2,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":17,"sex":51,"minAge":19,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":24,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":43},"100522386","investigation-of-the-effects-of-sleep-fragmentation-on-itch-and-pain-sensitivity-100522386","NCT06081946","Investigation of the Effects of Sleep Fragmentation on Itch and Pain Sensitivity","Investigation of the Effects of Sleep Provocations on Itch and Pain Sensitivity","Inclusion Criteria:\n\n* Healthy men and women\n* 18-60 years\n* Speak and understand English\n* Access to a smartphone during the experimental nights\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Drug addiction defined as any use of cannabis, opioids, or other drugs\n* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses (psychiatric diagnosis) that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia etc.)\n* Moles, wounds, scars, or tattoos in the area to be treated or tested\n* Current use of medications that may affect the trial such as antihistamines and pain killers.\n* Skin diseases\n* Consumption of alcohol or painkillers 24 hours before the study days and between these\n* Acute or chronic pain and itch\n* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)\n* Lack of ability to cooperate","60 Years",{"count":77,"type":23},30,[26],"In This experiment, the investigators would like to test following hypotheses regarding the influence of sleep fragmentation on itch:\n\n* To investigate similarity and differences between itch and pain by comparing the effect of sleep deprivation in them.\n* To evaluate the inflammatory state induced by sleep fragmentation via the analysis of C-reactive protein (CRP) levels from blood samples.\n* To correlate the anxiety and depression scores (evaluated through questionnaires) with itch and pain sensitivity and evaluate how they are affected by sleep fragmentation.",[81,82,30],"Histamine","Cowhage","2024-11-20",{"date":85,"type":35},"2024-11-22",{"date":87,"type":35},"2023-12-15",{"date":89,"type":23},"2026-12-31",{"name":91,"class":42},"Aalborg University",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":24,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":43},"100475771","sleepless-at-scripps-an-inpatient-white-noise-study-100475771","NCT05475262","Sleepless at Scripps: An Inpatient White Noise Study","Sleepless at Scripps: The Use of White Noise to Increase Sleep Duration in Hospitalized Patients, a Prospective Study","Inclusion Criteria:\n\n* Over 18 years old\n* Admitted to inpatient internal medicine service for at least 3 nights\n\nExclusion Criteria:\n\n\\-",{"count":100,"type":23},50,[26],"Sleep is an important part of the healing process, and patients admitted to the hospital often report poor sleep. Patients have difficulty not only falling sleep, but also staying asleep. Prior studies show that hospital noise may be a contributing factor, and in particular, sound level changes (which refers to an increase in sound above the background\u002Fbaseline noise level) may cause arousals from sleep. Based on preliminary data, this study aims to use white noise to reduce the number of relevant sound level changes that occur during a night of sleep in the hospital. Using a randomized, cross-over design, the investigators aim to enroll 45 inpatient adults (age ≥ 65 years) to receive \"active,\" white noise (white noised played at 57-60 decibels) on one night of their stay, and \"inactive,\" white noise (white noise played at 45-50 decibels) on an alternate night. Three major primary outcomes will be investigated - 1) objective sleep duration as measured using actigraphy, 2)objectively measured sleep fragmentation using actigraphy, and 3) subjective sleep quality using the Richards Campbell Sleep Questionnaire. Secondary outcomes will include sound level changes in the room (measured using sound meters), as well as morning blood glucose (for diabetic\u002Fprediabetic patients) and blood pressure measurements. Delirium will be measured twice daily through the inpatient stay in a secondary analysis to compare levels of sleep fragmentation to delirium incidence.",[104,105,30,106],"White Noise","Sleep","Sleep Duration","2024-01-22",{"date":109,"type":35},"2024-01-24",{"date":111,"type":35},"2022-07-28",{"date":113,"type":23},"2027-02-01",{"name":115,"class":42},"Scripps Health"]