[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642373":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":31,"collaborators":33,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":10,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"University of Split, School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adolescent Girls with Newly Diagnosed Anorexia Nervosa University Hospital of Split Day Hospital",null,"A single cohort of 25 female participants aged 10-18 years at the time of first diagnosis of anorexia nervosa (ICD-10: F50.0, F50.1, F50.9), enrolled consecutively at the Day Hospital for Children and Adolescents, Department of Psychiatry, University Hospital of Split (KBC Split), Croatia. All participants underwent identical baseline assessments (T0) at diagnosis and repeat assessments at 12-month follow-up (T1) following a structured multimodal treatment program.",[13,14,15],"Procedure: Longitudinal Fasting Blood Sampling for Biomarker Assessment","Other: Multimodal Psychiatric Treatment Program","Device: Home Polysomnography - NOX A1",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"PROCEDURE","Longitudinal Fasting Blood Sampling for Biomarker Assessment","Serial venous blood sampling conducted under standardized fasting conditions (minimum 8-hour fast) at baseline (T0) and 12-month follow-up (T1) for assessment of the following parameters:\n\nInflammatory markers:\n\n* Complete blood count with differential\n* Neutrophil-to-lymphocyte ratio (NLR)\n* C-reactive protein (CRP, mg\u002FL)\n\nHormonal and nutritional markers:\n\n* Free thyroxine (fT4), free triiodothyronine (fT3)\n* Prolactin\n* 25-hydroxyvitamin D (25OH-D)\n\nMetabolic markers:\n\n* Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (mmol\u002FL)",[9],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"Multimodal Psychiatric Treatment Program","Structured Day Hospital treatment program delivered over 12 months at the Department of Psychiatry comprising:\n\n1. Psychological intervention: Acceptance and Commitment Therapy (ACT) combined with Cognitive Behavioral Therapy (CBT), delivered in individual and group format, targeting cognitive distortions, body image disturbance, emotional regulation, and values-based behavioral change\n2. Supportive individual psychotherapy addressing motivation for recovery, self-esteem, and interpersonal functioning\n3. Family-based work and parent sessions including psychoeducation, family communication strategies and caregiver support\n4. Pharmacotherapy where clinically indicated by the treating child and adolescent psychiatrist; agent, dose, duration and modifications recorded systematically as covariates\n\nTreatment adherence, session attendance, adverse events, and changes in status are documented at each clinical contact throughout the 12-month.",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"DEVICE","Home Polysomnography - NOX A1","Ambulatory, wireless polysomnographic recording performed by the participant in their natural home environment using the NOX A1 portable device (Nox Medical, Iceland). The device records electroencephalography (EEG), electrooculography (EOG), chin electromyography (EMG), electrocardiography (ECG), respiratory effort , nasal airflow, pulse oximetry, body position, and actigraphy. Sleep staging is performed according to AASM 2023 scoring rules. Participants self-apply the device at home following standardized written and verbal instructions provided by the research team, eliminating first-night laboratory effects associated with traditional in-laboratory polysomnography. Derived sleep variables: total sleep time (TST, minutes), sleep efficiency (SE), sleep onset latency (SOL, minutes), wake after sleep onset (WASO, minutes), N1%, N2%, N3% slow-wave sleep (SWS), REM sleep %, REM latency (minutes), and arousal index. Measurements were conducted at baseline (T0) and 12-month follow-up (T1).",[9],{"type":32,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[34],{"name":35,"class":6},"University Hospital of Split","100642373","sleep-quality-and-biomarkers-in-adolescent-girls-with-anorexia-nervosa-100642373",false,"NCT07644728","Sleep Quality and Biomarkers in Adolescent Girls With Anorexia Nervosa","Sleep Architecture, Inflammatory and Hormonal Biomarkers, Psychopathology, and Quality of Life in Adolescent Girls With Anorexia Nervosa: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Female sex assigned at birth\n2. Age between 10 and 18 years (inclusive) at the time of study enrollment\n3. First-time diagnosis of anorexia nervosa according to ICD-10 criteria at the time of enrollment, including:\n\n   * Anorexia nervosa (F50.0)\n   * Atypical anorexia nervosa (F50.1)\n   * Eating disorder, unspecified (F50.9) with predominant restrictive or anorexic presentation\n4. Currently under the care of a child and adolescent psychiatrist at the Department of Psychiatry, University Hospital of Split (KBC Split), Croatia\n5. Enrolled in or eligible for the Day Hospital Program for Children and Adolescents at the Department of Psychiatry, KBC Split\n6. Ability to read and understand Croatian language sufficiently to complete self-report questionnaires\n7. Parent or legal guardian willing and able to provide written informed consent prior to any study procedure\n8. Participant willing and able to provide written assent prior to any study procedure\n9. Participant and parent\u002Fguardian willing to undergo all study procedures at both time points, including:\n\n   * Home polysomnography (NOX A1) at baseline and 12-month follow-up\n   * Completion of all self-report questionnaires at baseline and 12-month follow-up\n   * Fasting blood sampling at baseline and 12-month follow-up\n\nExclusion Criteria:\n\n1. Age younger than 10 years or older than 18 years at the time of enrollment\n2. Male sex assigned at birth\n3. Previous diagnosis of anorexia nervosa prior to current enrollment (i.e., recurrent or relapsing AN - this study enrolls first-diagnosis cases only)\n4. Anorexia nervosa currently in clinical remission at the time of enrollment\n5. Comorbid psychiatric diagnosis of any of the following:\n\n   * Intellectual disability (any severity, ICD-10: F70-F79)\n   * Autism spectrum disorder (ICD-10: F84)\n   * Schizophrenia spectrum or other psychotic disorder (ICD-10: F20-F29)\n   * Bipolar affective disorder, any type (ICD-10: F31)\n   * Substance use disorder, any substance (ICD-10: F10-F19)\n6. Severe or chronic somatic illness documented in medical history, including but not limited to:\n\n   * Central nervous system disorders (epilepsy, acquired brain injury, neurodegenerative disease, ICD-10: G00-G99)\n   * Chronic inflammatory or autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis)\n   * Primary endocrine disorder independent of AN (e.g., primary hypothyroidism, type 1 or type 2 diabetes mellitus, congenital adrenal hyperplasia)\n   * Active or history of malignancy\n   * Chronic renal or hepatic disease\n7. Use of any medication known to significantly alter sleep architecture or inflammatory biomarker levels that was initiated prior to study enrollment and is unrelated to the study treatment program, including:\n\n   * Benzodiazepines or z-drugs (zopiclone, zolpidem)\n   * Antipsychotic medications\n   * Systemic corticosteroids\n   * Immunosuppressive agents\n   * Melatonin or melatonin receptor agonists Medications initiated as part of the Day Hospital treatment program after enrollment will be documented and included as covariates in statistical analyses and do not constitute an exclusion criterion.\n8. Presence of an active somatic condition at the time of enrollment requiring acute inpatient medical treatment (e.g., severe electrolyte imbalance requiring intravenous correction, acute cardiac arrhythmia) that would preclude safe participation in the Day Hospital Program\n9. Physical or cognitive inability to cooperate with home polysomnography device placement or self-report questionnaire completion, as judged by the treating child and adolescent psychiatrist\n10. Simultaneous participation in another interventional clinical trial that could influence sleep parameters, nutritional status, inflammatory markers, or psychiatric outcomes.\n11. Absence of written informed consent from parent or legal guardian, or absence of written assent from the participant","FEMALE","10 Years","18 Years",{"count":47,"type":48},25,"ESTIMATED","OBSERVATIONAL","The purpose of this observational study is to systematically evaluate how a 12-month multimodal psychiatric treatment program affects sleep quality, inflammatory and hormonal biomarkers, eating disorder psychopathology, and health-related quality of life in adolescent girls (aged 10-18 years) diagnosed with anorexia nervosa.\n\nThe main questions it aims to answer are:\n\n* Do adolescent girls with anorexia nervosa have measurable changes in sleep patterns (total sleep time, sleep efficiency, REM sleep, deep sleep) compared to age- and sex-matched published values, and do these improve after 12 months of psychiatric treatment?\n* Are specific body markers (like NLR, CRP, vitamin D, and lipid profile) linked to how severe sleep problems, eating disorder symptoms, and treatment results are in this group?\n* To assess these outcomes, researchers will compare participants' baseline measurements to their own 12-month follow-up measurements to determine whether multimodal psychiatric treatment produces clinically meaningful improvements in sleep architecture, biomarker profiles, psychopathology, psychological flexibility, and quality of life.\n\nParticipants will:\n\n* Take-home sleep recordings with a wireless device (NOX A1) in their usual environment at the start and after 12 months of treatment.\n* Complete validated self-report questionnaires assessing sleep quality (PSQI), daytime sleepiness (ESS-CHAD for children and adolescents), eating disorder symptoms (EDE-Q), depression, anxiety, and stress (DASS-21), psychological flexibility (AFQ-Y8), and health-related quality of life (KIDSCREEN-52) at baseline and 12-month follow-up.\n* Give blood samples at the start and after 12 months for testing of inflammation markers, hormone levels, lipids, and anthropometric measurements.\n* Take part in a Day Hospital Program at the Department of Psychiatry, University Hospital of Split (KBC Split), Croatia, which includes Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, individual counselling, family work, and medication if needed.",[52],"Anorexia Nervosa",[52,54,55,56,57,58,59],"Sleep Quality","Adolescents, Female","Eating Behaviour","Mental Health","Quality of life","Inflammatory markers","NOT_YET_RECRUITING","2026-06-08",{"date":63,"type":64},"2026-06-12","ACTUAL",{"date":66,"type":48},"2026-05-30",{"date":68,"type":48},"2029-12-31",{"name":5,"class":6}]