Sleep Quality and Biomarkers in Adolescent Girls With Anorexia Nervosa

NCT07644728 | Not Yet Recruiting

• 1 other identifier: 520-03/26-01/95
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Anorexia Nervosa; Sleep Quality; Adolescents, Female; Eating Behaviour; Mental Health; Quality of life; Inflammatory markers

Outcome Measures

Primary Outcomes (3)

• Change in Objective Sleep Architecture Assessed by Home Polysomnography (NOX A1)

  Change from baseline in polysomnographically derived sleep parameters measured by the portable wireless NOX A1 device in the participant's home environment. Sleep staging performed according to AASM 2023 scoring criteria. Change from baseline in sleep efficiency (SE, %) as the primary polysomnographic outcome, measured by the portable wireless NOX A1 device in the participant's home environment. SE is defined as the ratio of total sleep time to time in bed, expressed as a percentage. This is the single primary reported value for this outcome measure. Additional polysomnographic parameters (total sleep time in minutes, sleep onset latency in minutes, wake after sleep onset in minutes, N1/N2/N3/REM sleep percentages, REM latency in minutes, arousal index in events/hour) will be reported as pre-specified secondary descriptive analyses, each in its respective unit of measure, and are not aggregated into a composite score. Unit of Measure: Percentage (%)

  Baseline (T0 - at first diagnosis) and 12 months (T1 - following completion of multimodal treatment program)

• Change in Subjective Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline in the Global PSQI Score as the single primary reported value. The Global PSQI Score is calculated as the sum of seven component scores and ranges from 0 to 21, with higher scores indicating worse sleep quality. A score greater than 5 indicates poor sleep quality. The seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction) share the same unit of measure (score on a scale, range 0-3 per component) and will be reported as supplementary descriptive analyses. Unit of Measure: Score on a scale (0-21)

  Baseline (T0 - at first diagnosis) and 12 months (T1 - following completion of multimodal treatment program)

• Change in Eating Disorder Psychopathology Assessed by the Eating Disorder Examination Questionnaire (EDE-Q)

  Change from baseline in EDE-Q global score and four subscale scores: * Restraint * Eating Concern * Shape Concern * Weight Concern Each item rated on a 7-point forced-choice scale (0-6). Global score calculated as mean of four subscale scores. Higher scores indicate greater eating disorder psychopathology.

  Baseline (T0 - at first diagnosis) and 12 months (T1 - following completion of multimodal treatment program)

Secondary Outcomes (12)

• Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale - Participant Version (ESS)

  Baseline (T0) and 12 months (T1)

• Change in Daytime Sleepiness Assessed by the Epworth Sleepiness Scale - Parent/Caregiver Version (ESS-Parent)

  Baseline (T0) and 12 months (T1)

• Change in Depression, Anxiety, and Stress Assessed by the Depression Anxiety Stress Scale - 21 Items (DASS-21)

  Baseline (T0) and 12 months (T1)

• Change in Psychological Flexibility Assessed by the Avoidance and Fusion Questionnaire for Youth - 8 Items (AFQ-Y8)

  Baseline (T0) and 12 months (T1)

• Change in Health-Related Quality of Life Assessed by KIDSCREEN-52 - Participant Self-Report Version

  Baseline (T0) and 12 months (T1)

Study Arms (1)

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.

Procedure: Longitudinal Fasting Blood Sampling for Biomarker Assessment; Other: Multimodal Psychiatric Treatment Program; Device: Home Polysomnography - NOX A1

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)

Adolescent Girls with Newly Diagnosed Anorexia Nervosa University Hospital of Split Day Hospital

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.

Adolescent Girls with Newly Diagnosed Anorexia Nervosa University Hospital of Split Day Hospital

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).

Adolescent Girls with Newly Diagnosed Anorexia Nervosa University Hospital of Split Day Hospital

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients aged 10-18 years with a first-time 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. Participants must be medically stable for Day Hospital treatment and able to complete home polysomnography and self-report questionnaires in Croatian. Excluded are patients with intellectual disability, autism spectrum disorder, psychotic or bipolar disorder, substance use disorder, chronic somatic illness affecting inflammatory markers, or prior AN diagnosis.

You may qualify if:

• Female sex assigned at birth
• Age between 10 and 18 years (inclusive) at the time of study enrollment
• First-time diagnosis of anorexia nervosa according to ICD-10 criteria at the time of enrollment, including:
• Anorexia nervosa (F50.0)
• Atypical anorexia nervosa (F50.1)
• Eating disorder, unspecified (F50.9) with predominant restrictive or anorexic presentation
• Currently under the care of a child and adolescent psychiatrist at the Department of Psychiatry, University Hospital of Split (KBC Split), Croatia
• Enrolled in or eligible for the Day Hospital Program for Children and Adolescents at the Department of Psychiatry, KBC Split
• Ability to read and understand Croatian language sufficiently to complete self-report questionnaires
• Parent or legal guardian willing and able to provide written informed consent prior to any study procedure
• Participant willing and able to provide written assent prior to any study procedure
• Participant and parent/guardian willing to undergo all study procedures at both time points, including:
• Home polysomnography (NOX A1) at baseline and 12-month follow-up
• Completion of all self-report questionnaires at baseline and 12-month follow-up
• Fasting blood sampling at baseline and 12-month follow-up

You may not qualify if:

• Age younger than 10 years or older than 18 years at the time of enrollment
• Male sex assigned at birth
• Previous diagnosis of anorexia nervosa prior to current enrollment (i.e., recurrent or relapsing AN - this study enrolls first-diagnosis cases only)
• Anorexia nervosa currently in clinical remission at the time of enrollment
• Comorbid psychiatric diagnosis of any of the following:
• Intellectual disability (any severity, ICD-10: F70-F79)
• Autism spectrum disorder (ICD-10: F84)
• Schizophrenia spectrum or other psychotic disorder (ICD-10: F20-F29)
• Bipolar affective disorder, any type (ICD-10: F31)
• Substance use disorder, any substance (ICD-10: F10-F19)
• Severe or chronic somatic illness documented in medical history, including but not limited to:
• Central nervous system disorders (epilepsy, acquired brain injury, neurodegenerative disease, ICD-10: G00-G99)
• Chronic inflammatory or autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis)
• Primary endocrine disorder independent of AN (e.g., primary hypothyroidism, type 1 or type 2 diabetes mellitus, congenital adrenal hyperplasia)
• Active or history of malignancy

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• University Hospital of Split: collaborator

MeSH Terms

Conditions

Anorexia Nervosa; Sleep Initiation and Maintenance Disorders; Feeding Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavior, Animal; Behavior; Personal Satisfaction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 12, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share