Sleep and Activity For Eating Disorders (NCT07295470) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sleep and Activity For Eating Disorders
Italy75 participantsStarted 2026-02
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep efficiency (SE)
Timeframe: 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).
2
Chronotype
Timeframe: 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).
3
Orexin Levels
Timeframe: At the beginning of the recovery (Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).