Sleep Quality and Biomarkers in Adolescent Girls With Anorexia Nervosa

Summary

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.

Conditions

• Anorexia Nervosa

Interventions

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: 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)

OTHER

Multimodal Psychiatric Treatment Program

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.

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).

Sponsors & Collaborators

• University Hospital of Split

  collaborator OTHER

• University of Split, School of Medicine

  lead OTHER

Eligibility

Min Age

10 Years

Max Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-30

Primary Completion

2028-05-30

Completion

2029-12-31