Eating DisordersSAFENCT07295470
Sleep and Activity For Eating Disorders
A study testing Actigraphy, Collection of biological parameters and Psychological testing in people with Eating Disorders and Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Actigraphy, Collection of biological parameters and Psychological testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carolina Lombardi, MD contact
Italy1 site
Istituto Auxologico Italiano - S. Giuseppe Hospital
Verbania, VB, 28824
Carolina Lombardi, 0039 347 3179580, c.lombardi@auxologico.it
About this study
Official title: 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).
Read the 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:
- actigraphy combined with salivary melatonin measurement;
- collection of self-report data regarding sleep characteristics and dream content (e.g., sleep and dream diary);
- 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:
- validated self-report questionnaires assessing sleep characteristics (PSQI) and circadian rhythms (rMEQ);
- 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).
- Being tested
- Actigraphy, Collection of biological parameters, Psychological testing
- Keywords
- Sleep, Circadian rhythms, Eating disorders
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphyDevice
Also called Actigraphic measurements of sleep
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 parametersBiological
Also called Biological draws (blood and salivary)
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 testingOther
Also called Psychological testing through self-report measures or instruments administered by clinicians
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 group | Role | What they receive |
|---|---|---|
| Patients with anorexia nervosa | Other | Examinations of sleep, circadian rhythms, physical activity and psychological features Receives: 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 Receives: 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 Receives: Device: Actigraphy; Biological: Collection of biological parameters; Other: Psychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency (SE)
Sleep efficiency will be detected through actigraphic measurements and will be compared either within and among groups.
Measured: 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.
Measured: 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.
Measured: At the beginning of the recovery (Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startFeb 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Sponsor
- Investigators
- Luigi De Gennaro, Study director, University of Roma La SapienzaLeonardo Mendolicchio, MD, Study director, Istituto Auxologico ItalianoSerena Scarpelli, PhD, Study director, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295470
- Sponsor's protocol ID
- 09C525
- Other IDs
- 55/25
- Acronym
- SAFE
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Activity For Eating Disorders (SAFE): a Cross-sectional and Prospective Study on the Sleep Parameters.
- ClinicalTrials.gov ID
- NCT07295470
- Acronym / sponsor ID
- SAFE / 09C525
- Keywords
- Sleep, Circadian rhythms, Eating disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- actigraphy combined with salivary melatonin measurement;
- collection of self-report data regarding sleep characteristics and dream content (e.g., sleep and dream diary);
- 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:
- validated self-report questionnaires assessing sleep characteristics (PSQI) and circadian rhythms (rMEQ);
- 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with anorexia nervosa | Other | Device: Actigraphy, Biological: Collection of biological parameters, Other: Psychological testingExaminations of sleep, circadian rhythms, physical activity and psychological features |
| Patients with bulimia nervosa | Other | Device: Actigraphy, Biological: Collection of biological parameters, Other: Psychological testingExaminations of sleep, circadian rhythms, physical activity and psychological features |
| Patients with binge-eating disorder | Other | Device: Actigraphy, Biological: Collection of biological parameters, Other: Psychological testingExaminations of sleep, circadian rhythms, physical activity and psychological features |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActigraphyAlso: Actigraphic measurements of sleepThe 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). | Device | Patients with anorexia nervosa, Patients with binge-eating disorder, Patients with bulimia nervosa |
| Collection of biological parametersAlso: Biological draws (blood and salivary)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. | Biological | Patients with anorexia nervosa, Patients with binge-eating disorder, Patients with bulimia nervosa |
| Psychological testingAlso: Psychological testing through self-report measures or instruments administered by cliniciansParticipants 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 | Patients with anorexia nervosa, Patients with binge-eating disorder, Patients with bulimia nervosa |
Primary outcome
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).
Sleep efficiency will be detected through actigraphic measurements and will be compared either within and among groups.
Chronotype
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).
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.
Orexin Levels
Time frame: At the beginning of the recovery (Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).
Levels of orexin detected through blood exams.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolina Lombardi, MD contact
Luigi De Gennaro study director
University of Roma La Sapienza
Leonardo Mendolicchio, MD study director
Istituto Auxologico Italiano
Serena Scarpelli, PhD study director
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraphy, Collection of biological parameters and Psychological testing in people with Eating Disorders and Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Cera, MSc (0039 3275508693, g.cera@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.