Sleep and Activity For Eating Disorders (SAFE)

Sleep and Activity For Eating Disorders (SAFE): a Cross-sectional and Prospective Study on the Sleep Parameters.

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Anorexia Nervosa; Bulimia Nervosa; Eating Disorders; Binge Eating Disorder
• Intervention / Treatment: Device: Actigraphy; Biological: Collection of biological parameters; Other: Psychological testing

Detailed Description

The central aim of the study is to describe sleep characteristics in a population of patients with eating disorders (i.e., anorexia nervosa, bulimia nervosa, and binge-eating disorder) attending the Center for Eating and Nutrition Disorders of the Istituto Auxologico Italiano (Piancavallo branch) - San Giuseppe Hospital.

Sleep will be characterized through the following assessments:

1. actigraphy combined with salivary melatonin measurement;
2. collection of self-report data regarding sleep characteristics and dream content (e.g., sleep and dream diary);
3. validated self-report questionnaires assessing sleep characteristics (Pittsburgh Sleep Quality Index - PSQI) and circadian rhythms (- reduced version of the Morningness-Eveningness Questionnaire - rMEQ).

Specifically, sleep characteristics will be assessed at home, during the month preceding admission to Piancavallo (Time 0), through:

1. validated self-report questionnaires assessing sleep characteristics (PSQI) and circadian rhythms (rMEQ);
2. collection of self-report data regarding sleep characteristics and dream content (e.g., sleep and dream diary), as well as actigraphy for at least one week.

Subsequently, throughout the entire inpatient stay (Time 1: first day of admission; Time 2: midpoint of the admission - 4 weeks; Time 3: the night before discharge), patients will be monitored using actigraphy and will undergo salivary melatonin measurement on the first and last day before discharge. During the same period, daily self-report data on sleep characteristics and dream content (e.g., sleep and dream diary) will be collected.

In these same patients, in addition to age, sex, anthropometric data, and blood chemistry parameters (including ghrelin, leptin, and orexin levels), as well as ongoing pharmacological treatment, the following will be assessed: presence and severity of body image distortion (Body Uneasiness Test - BUT , and Body Image Task - BIT), mood disorders (Beck's Depression Inventory - BDI, and Hospital Anxiety and Depression Scale - HADS), social anxiety related to physical appearance (Social Appearance Anxiety Scale - SAAS), severity of the eating disorder (Eating Disorder Inventory-3 - EDI-3, Yale-Food Addiction Scale - YFAS, and Binge Eating Scale - BES), intensity of the urge to engage in physical activity (State Urge to be Physically Active Questionnaire - SUPAQ), and individual differences in the expression of personality traits (HEXACO adjectives list). Measurements obtained through these psychometric tests will be collected at three timepoints: upon admission to the unit for rehabilitation (Time 1), around the midpoint of the rehabilitation program (Time 2: 4 weeks after admission), and at discharge (Time 3).

The secondary objectives will also include the following:

• Assessing the correlation of the above parameters with the intensity, duration, and circadian distribution of daytime physical activity using actigraphy and validated scales (SUPAQ); actigraphy will also allow the evaluation of several nighttime sleep parameters: sleep duration, number of awakenings, and sleep efficiency (e.g., ratio of sleep time to time in bed);
• Assessing the relationship between sleep patterns and the degree of body image distortion as measured through the BIT, which examines body-part metrics and allows calculation of the distortion index between real body measurements and those implicitly perceived by the subject, and the BUT, an additional measure of perceived inadequacy regarding one's body;
• Assessing the influence of mood disorders measured through structured interviews and standardized questionnaires (BDI-II and HADS) on sleep characteristics and eating disorder severity in the population described above;
• Assessing the influence of chronotype (e.g., morning, evening, or intermediate), investigated through the rMEQ questionnaire, on eating disorder symptomatology and on the expression of different personality traits, assessed through self-report questionnaires (HEXACO).

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulia Cera, MSc; Phone Number: 0039 3275508693; Email: g.cera@auxologico.it
• Study Contact Backup: Name: Carolina Lombardi, MD; Email: c.lombardi@auxologico.it

Study Locations

• Italy
  • VB
    • Verbania, VB, Italy, 28824
      • Istituto Auxologico Italiano - S. Giuseppe Hospital
      • Contact: Carolina Lombardi; Phone Number: 0039 347 3179580; Email: c.lombardi@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with anorexia nervosa; Examinations of sleep, circadian rhythms, physical activity and psychological features	Device: Actigraphy; 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).; Other Names: Actigraphic measurements of sleep; Biological: Collection of biological parameters; 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.; Other Names: Biological draws (blood and salivary); Other: Psychological testing; 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).; Other Names: Psychological testing through self-report measures or instruments administered by clinicians
Other: Patients with bulimia nervosa; Examinations of sleep, circadian rhythms, physical activity and psychological features	Device: Actigraphy; 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).; Other Names: Actigraphic measurements of sleep; Biological: Collection of biological parameters; 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.; Other Names: Biological draws (blood and salivary); Other: Psychological testing; 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).; Other Names: Psychological testing through self-report measures or instruments administered by clinicians
Other: Patients with binge-eating disorder; Examinations of sleep, circadian rhythms, physical activity and psychological features	Device: Actigraphy; 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).; Other Names: Actigraphic measurements of sleep; Biological: Collection of biological parameters; 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.; Other Names: Biological draws (blood and salivary); Other: Psychological testing; 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).; Other Names: Psychological testing through self-report measures or instruments administered by clinicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: University of Roma La Sapienza
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Sleep; Circadian rhythms; Eating disorders
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Binge-Eating Disorder; Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Behavioral Disciplines and Activities; Monitoring, Physiologic; Accelerometry; Psychological Tests; Blood Specimen Collection; Actigraphy
• Other Study ID Numbers: 09C525; 55/25 (Other Identifier: Istituto Auxologico Italiano)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No