Health TrialsbyHealthPanel

Sleep and Activity For Eating Disorders

ConditionsEating DisordersAnorexia NervosaBulimia NervosaBinge Eating Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstituto Auxologico Italiano

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Actigraphy

    Device

    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 parameters

    Biological/Vaccine

    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 testing

    Other intervention

    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).

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Patients with anorexia nervosaOther 3 interventions
Group B: Patients with bulimia nervosaOther 3 interventions
Group C: Patients with binge-eating disorderOther 3 interventions

Trial outcomes

Primary outcomes

1

Sleep efficiency (SE)

Sleep efficiency will be detected through actigraphic measurements and will be compared either within and among groups.

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).
2

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.

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).
3

Orexin Levels

Levels of orexin detected through blood exams.

Time frame
At the beginning of the recovery (Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).

Secondary outcomes

Other outcomes

Sponsors and contacts

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Istituto Auxologico Italiano

Lead sponsor

University of Roma La Sapienza

Collaborator

Source ClinicalTrials.gov

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