[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615658":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":51,"locations":61,"responsibleParty":79,"collaborators":81,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":56,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":110,"whyStopped":56,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Istituto Auxologico Italiano","OTHER",[8,15,18],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients with anorexia nervosa","Examinations of sleep, circadian rhythms, physical activity and psychological features",[12,13,14],"Device: Actigraphy","Biological: Collection of biological parameters","Other: Psychological testing",{"label":16,"type":6,"description":10,"interventionNames":17},"Patients with bulimia nervosa",[12,13,14],{"label":19,"type":6,"description":10,"interventionNames":20},"Patients with binge-eating disorder",[12,13,14],[22,29,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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).",[9,19,16],[28],"Actigraphic measurements of sleep",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"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.",[9,19,16],[35],"Biological draws (blood and salivary)",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"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).",[9,19,16],[41],"Psychological testing through self-report measures or instruments administered by clinicians",[43,47,49],{"name":44,"affiliation":45,"role":46},"Luigi De Gennaro","University of Roma La Sapienza","STUDY_DIRECTOR",{"name":48,"affiliation":5,"role":46},"Leonardo Mendolicchio, MD",{"name":50,"affiliation":45,"role":46},"Serena Scarpelli, PhD",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Giulia Cera, MSc","CONTACT","0039 3275508693",null,"g.cera@auxologico.it",{"name":59,"role":54,"phone":56,"phoneExt":56,"email":60},"Carolina Lombardi, MD","c.lombardi@auxologico.it",[62],{"facility":63,"status":56,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Istituto Auxologico Italiano - S. Giuseppe Hospital","Verbania","VB","28824","Italy","IT",{"type":70,"coordinates":71},"Point",[72,73],8.55183,45.92136,{"lat":73,"lon":72},[76],{"name":77,"role":54,"phone":78,"phoneExt":56,"email":60},"Carolina Lombardi","0039 347 3179580",{"type":80,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR",[82],{"name":45,"class":6},"100615658","sleep-and-activity-for-eating-disorders-100615658",false,"NCT07295470","Sleep and Activity For Eating Disorders","Sleep and Activity For Eating Disorders (SAFE): a Cross-sectional and Prospective Study on the Sleep Parameters.","SAFE","Inclusion Criteria:\n\n* a) Age over 18 and under 65;\n* b) Diagnosis of anorexia nervosa, bulimia nervosa, or binge-eating disorder, as indicated by DSM-5-TR criteria;\n* c) Adherence to the rehabilitation program.\n\nExclusion Criteria:\n\n* a) Presence of severe bradycardia (BPM \\\u003C 35);\n* b) Severe malnutrition (BMI \\\u003C 10);\n* c) Presence of severe psychopathology other than the eating disorder (e.g., schizophrenia);\n* d) Need to modify psychotropic or sleep-inducing pharmacological therapy during the rehabilitation program.","ALL","18 Years","65 Years",{"count":95,"type":96},75,"ESTIMATED","INTERVENTIONAL",[99],"NA","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).",[102,103,104,105],"Eating Disorders","Anorexia Nervosa","Bulimia Nervosa","Binge Eating Disorder",[107,108,109],"Sleep","Circadian rhythms","Eating disorders","NOT_YET_RECRUITING","2025-12-16",{"date":113,"type":114},"2025-12-19","ACTUAL",{"date":116,"type":96},"2026-02",{"date":118,"type":96},"2027-07",{"name":5,"class":6},1]