Sleep and Activity For Eating Disorders
Key facts
- Who runs it
- Istituto Auxologico Italiano
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 75 people, planned
- Started
- 1 Jul 2026
- Expected to end
- Jul 2027
- Type of study
- Interventional, 3 groups
- Treatments tested
- Actigraphy
- Collection of biological parameters
- Psychological testing
- Record updated
- 4 November 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- d) Need to modify psychotropic or sleep-inducing pharmacological therapy during the rehabilitation program
- c) Presence of severe psychopathology other than the eating disorder (e.g., schizophrenia)
- a) Presence of severe bradycardia (BPM < 35)
- b) Severe malnutrition (BMI < 10)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
The 3 groups in the trial
- Patients with anorexia nervosaOther group
Examinations of sleep, circadian rhythms, physical activity and psychological features
Treatment: Actigraphy, Collection of biological parameters, and Psychological testing
- Patients with bulimia nervosaOther group
Examinations of sleep, circadian rhythms, physical activity and psychological features
Treatment: Actigraphy, Collection of biological parameters, and Psychological testing
- Patients with binge-eating disorderOther group
Examinations of sleep, circadian rhythms, physical activity and psychological features
Treatment: Actigraphy, Collection of biological parameters, and Psychological testing
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sleep and Activity For Eating Disorders (SAFE): a Cross-sectional and Prospective Study on the Sleep Parameters.
- Fit questions
- Built from NCT07295470, who can take part
- Record updated
- 4 November 2026