Sleep and Activity For Eating Disorders (SAFE)

Istituto Auxologico Italiano

Status: Not yet enrolling

Conditions: Bulimia Nervosa; Eating Disorders; Anorexia Nervosa; Binge Eating Disorder

Treatments: Device: Actigraphy; Biological: Collection of biological parameters; Other: Psychological testing

Study type: Interventional

Funder types: Other

Identifiers

NCT07295470

09C525

55/25 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Patients with anorexia nervosa

Other group

Description:

Examinations of sleep, circadian rhythms, physical activity and psychological features

Treatment:

Other: Psychological testing

Biological: Collection of biological parameters

Device: Actigraphy

Patients with bulimia nervosa

Other group

Description:

Examinations of sleep, circadian rhythms, physical activity and psychological features

Treatment:

Other: Psychological testing

Biological: Collection of biological parameters

Device: Actigraphy

Patients with binge-eating disorder

Other group

Description:

Examinations of sleep, circadian rhythms, physical activity and psychological features

Treatment:

Other: Psychological testing

Biological: Collection of biological parameters

Device: Actigraphy