Sleep and Activity For Eating Disorders (SAFE): a Cross-sectional and Prospective Study on the Sleep Parameters.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Sleep efficiency (SE)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with anorexia nervosa
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Actigraphy (Device)
Patients with anorexia nervosa
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Collection of biological parameters (Biological)
Patients with anorexia nervosa
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Psychological testing (Other)
Patients with bulimia nervosa
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Actigraphy (Device)
Patients with bulimia nervosa
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Collection of biological parameters (Biological)
Patients with bulimia nervosa
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Psychological testing (Other)
Patients with binge-eating disorder
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Actigraphy (Device)
Patients with binge-eating disorder
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Collection of biological parameters (Biological)
Patients with binge-eating disorder
Examinations of sleep, circadian rhythms, physical activity and psychological features
干预措施: Psychological testing (Other)
结局指标
主要结局
Sleep efficiency (SE)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点