Sleep and Activity For Eating Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Actigraphy, Collection of biological parameters, Psychological testing.
- Who it may be relevant to
- Registry conditions: Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sleep and Activity For Eating Disorders (SAFE): a Cross-sectional and Prospective Study on the Sleep Parameters.
Overview
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:
1. actigraphy combined with salivary melatonin measurement; 2. collection of self-report data regarding sleep characteristics and dream content (e.g., sleep and dream diary); 3. 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:
1. validated self-report questionnaires assessing sleep characteristics (PSQI) and circadian rhythms (rMEQ); 2. 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).
Interventions
- 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, d - 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. - Other 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 Depres
Primary outcome measures
- 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).]
- 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).]
- 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Italy · 1 center
- Istituto Auxologico Italiano - S. Giuseppe Hospital — Verbania
Identifiers
NCT: NCT07295470 · 09C525 · 55/25