Sleep and Activity For Eating Disorders

NCT07295470 | Not Yet Recruiting

• 2 other identifiers: 09C52555/25
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The SAFE (i.e., Sleep and Activity For Eating disorders) study aims to investigate the characteristics of sleep, daytime activity, and circadian rhythms in a sample of patients with eating disorders-specifically anorexia nervosa, bulimia nervosa, and binge-eating disorder-as well as the relationship between these variables and physiological parameters (i.e., body mass index, hormone levels, blood chemistry parameters) and psychological parameters (i.e., levels of depression and anxiety, body image, eating-disorder symptoms).

Conditions

Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge Eating Disorder

Keywords

Sleep; Circadian rhythms; Eating disorders

Outcome Measures

Primary Outcomes (3)

• Sleep efficiency (SE)

  Sleep efficiency will be detected through actigraphic measurements and will be compared either within and among groups.

  A week before the rehabilitation recovery (Time 0), at the beginning of the recovery (Time 1), half of the recovery (Time 2 - after 4 weeks from Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).

• Chronotype

  Chronotype is the propensity for the individual to engage in certain activities (i.e., sleep) at a particular time during a 24-hour period. It will be detected through a self-report measure, the Morningness-Eveningness Questionnaire, in its reduced version. The scale is composed by 5 items evaluating: a) preferred time for waking up, b) preferred time for going to bed, c) subjective peak alertness during the day, d) ease of getting out of bed, and e) self-assessment of being a "morning" or "evening" type. The total score ranges from 4 to 26, with the following threshold and interpretation: a) 4-10: Evening type, b) 11-18: Intermediate type, c) 19-26: Morning type.

  A week before the rehabilitation recovery (Time 0), at the beginning of the recovery (Time 1), half of the recovery (Time 2 - after 4 weeks from Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).

• Orexin Levels

  Levels of orexin detected through blood exams.

  At the beginning of the recovery (Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).

Study Arms (3)

Patients with anorexia nervosa

OTHER

Examinations of sleep, circadian rhythms, physical activity and psychological features

Device: Actigraphy; Biological: Collection of biological parameters; Other: Psychological testing

Patients with bulimia nervosa

OTHER

Examinations of sleep, circadian rhythms, physical activity and psychological features

Device: Actigraphy; Biological: Collection of biological parameters; Other: Psychological testing

Patients with binge-eating disorder

OTHER

Examinations of sleep, circadian rhythms, physical activity and psychological features

Device: Actigraphy; Biological: Collection of biological parameters; Other: Psychological testing

Interventions

Actigraphy DEVICE

The actigraph is a non-invasive device used to measure sleep-wake rhythms based on the recording of motor activity over a 24-hour period (Acker et al., 2021). Since it is easy to handle due to its physical characteristics, it can be worn for extended periods and therefore allows the collection of data related to activity and rest phases, as well as circadian rhythms. Specifically, the use of this method allows the collection of measures relating both to daytime motor activity (i.e., intensity, duration, and circadian distribution) and to nighttime sleep (i.e., duration, sleep-onset latency, wake period, number of awakenings, efficiency index, sleep and wake times).

Also known as: Actigraphic measurements of sleep

Patients with anorexia nervosa; Patients with binge-eating disorder; Patients with bulimia nervosa

Psychological testing OTHER

Participants will be asked to complete: a) Pittsburgh Sleep Quality Index (to measure subjective sleep quality); b) Morningness-Eveningness questionnaire (to measure the chronotype); c) Body Uneasiness Test (to measure body image uneasiness); d) Body Image Task (to measure the implicit perception of body image); e) Eating Disorder Inventory-3, Binge Eating Scale, Yale Food Addiction Scale (to measure the severity of eating symptoms); f) Beck Depression Inventory - II, Hospital anxiety and Depression Scale, Social Appearance Anxiety Scale (to measure depression levels); g) State Urge to be Physically Active Questionnaire (to measure physical activity levels); h) HEXACO list of adjectives (to evaluate personality traits).

Also known as: Psychological testing through self-report measures or instruments administered by clinicians

Patients with anorexia nervosa; Patients with binge-eating disorder; Patients with bulimia nervosa

Collection of biological parameters BIOLOGICAL

Some medical parameters will be collected, including blood pressure, heart rate, respiratory rate, blood levels of ghrelin, leptin, and orexin, as well as salivary melatonin levels.

Also known as: Biological draws (blood and salivary)

Patients with anorexia nervosa; Patients with binge-eating disorder; Patients with bulimia nervosa

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a) Age over 18 and under 65;
• b) Diagnosis of anorexia nervosa, bulimia nervosa, or binge-eating disorder, as indicated by DSM-5-TR criteria;
• c) Adherence to the rehabilitation program.

You may not qualify if:

• a) Presence of severe bradycardia (BPM \< 35);
• b) Severe malnutrition (BMI \< 10);
• c) Presence of severe psychopathology other than the eating disorder (e.g., schizophrenia);
• d) Need to modify psychotropic or sleep-inducing pharmacological therapy during the rehabilitation program.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

Istituto Auxologico Italiano - S. Giuseppe Hospital

Verbania, VB, 28824, Italy

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Interventions

Actigraphy; Blood Specimen Collection; Psychological Tests

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Behavioral Disciplines and Activities

Study Officials

• Luigi De Gennaro

  University of Roma La Sapienza

  STUDY DIRECTOR

• Leonardo Mendolicchio, MD

  Istituto Auxologico Italiano

  STUDY DIRECTOR

• Serena Scarpelli, PhD

  University of Roma La Sapienza

  STUDY DIRECTOR

Central Study Contacts

Giulia Cera, MSc

CONTACT

0039 3275508693; g.cera@auxologico.it

Carolina Lombardi, MD

CONTACT

c.lombardi@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 19, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (1)