Sleep Quality and Biomarkers in Adolescent Girls With Anorexia Nervosa

Sponsor
University of Split, School of Medicine
Study ID
NCT07644728
Status
Not Yet Recruiting

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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Longitudinal Fasting Blood Sampling for Biomarker Assessment — PROCEDURE
    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: Inflammatory markers: * Complete blood count with differential * Neutrophil-to-lymphocyte ratio (NLR) * C-reactive protein (CRP, mg/L) Hormonal and nutritional markers: * Free thyroxine (fT4), free triiodothyronine (fT3) * Prolactin * 25-hydroxyvitamin D (25OH-D) Metabolic markers: * Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (mmol/L)
  • Multimodal Psychiatric Treatment Program — OTHER
    Structured Day Hospital treatment program delivered over 12 months at the Department of Psychiatry comprising: 1. 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 2. Supportive individual psychotherapy addressing motivation for recovery, self-esteem, and interpersonal functioning 3. Family-based work and parent sessions including psychoeducation, family communication strategies and caregiver support 4. Pharmacotherapy where clinically indicated by the treating child and adolescent psychiatrist; agent, dose, duration and modifications recorded systematically as covariates Treatment adherence, session attendance, adverse events, and changes in status are documented at each clinical contact throughout the 12-month.
  • Home Polysomnography - NOX A1 — DEVICE
    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).

Study Details

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. The main questions it aims to answer are: * 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? * 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? * 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. Participants will: * Take-home sleep recordings with a wireless device (NOX A1) in their usual environment at the start and after 12 months of treatment. * 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. * Give blood samples at the start and after 12 months for testing of inflammation markers, hormone levels, lipids, and anthropometric measurements. * 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.

Key Dates

First listed
Jun 12, 2026
Start date
May 30, 2026
Status verified
May 2026
Primary completion
May 30, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: Adolescent Girls with Newly Diagnosed Anorexia Nervosa University Hospital of Split Day Hospital
    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.

Primary Outcome Measure

Change in Objective Sleep Architecture Assessed by Home Polysomnography (NOX A1) [ Time Frame: Baseline (T0 - at first diagnosis) and 12 months (T1 - following completion of multimodal treatment program) ]

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