Sleep and Activity For Eating Disorders

Sponsor
Istituto Auxologico Italiano
Study ID
NCT07295470
Status
Not Yet Recruiting

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Conditions

  • Anorexia Nervosa
  • Binge Eating Disorder
  • Bulimia Nervosa
  • Eating Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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).
  • 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.
  • 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).

Study Details

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).

Key Dates

First listed
Dec 19, 2025
Start date
Feb 28, 2026
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Patients with anorexia nervosa
    Examinations of sleep, circadian rhythms, physical activity and psychological features
  • Other: Patients with bulimia nervosa
    Examinations of sleep, circadian rhythms, physical activity and psychological features
  • Other: Patients with binge-eating disorder
    Examinations of sleep, circadian rhythms, physical activity and psychological features

Primary Outcome Measure

Sleep efficiency (SE) [ Time Frame: 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). ]

Central Contacts

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