Sueño y Actividad para Trastornos de la Conducta Alimentaria (SAFE)
Sueño y Actividad para Trastornos de la Conducta Alimentaria (SAFE): un Estudio Transversal y Prospectivo sobre los Parámetros del Sueño.
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).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
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).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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VB
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Verbania, VB, Italia, 28824
- Istituto Auxologico Italiano - S. Giuseppe Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Patients with anorexia nervosa
Examinations of sleep, circadian rhythms, physical activity and psychological features |
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).
Otros nombres:
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.
Otros nombres:
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).
Otros nombres:
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|
Otro: Patients with bulimia nervosa
Examinations of sleep, circadian rhythms, physical activity and psychological features |
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).
Otros nombres:
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.
Otros nombres:
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).
Otros nombres:
|
|
Otro: Patients with binge-eating disorder
Examinations of sleep, circadian rhythms, physical activity and psychological features |
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).
Otros nombres:
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.
Otros nombres:
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).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sleep efficiency (SE)
Periodo de tiempo: 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).
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Sleep efficiency will be detected through actigraphic measurements and will be compared either within and among groups. |
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).
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Chronotype
Periodo de tiempo: 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. |
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).
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Orexin Levels
Periodo de tiempo: At the beginning of the recovery (Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).
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Levels of orexin detected through blood exams. |
At the beginning of the recovery (Time 1) and at the end of the recovery (Time 3 - 7 weeks from Time 1).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Luigi De Gennaro, University of Roma La Sapienza
- Director de estudio: Leonardo Mendolicchio, MD, Istituto Auxologico Italiano
- Director de estudio: Serena Scarpelli, PhD, University of Roma La Sapienza
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Signos y Síntomas Digestivos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Trastorno por atracones
- Trastornos de la alimentación y la alimentación
- Anorexia nerviosa
- Bulimia nerviosa
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Puntas
- Procedimientos quirúrgicos, operativo
- Disciplinas y actividades de comportamiento
- Monitoreo, fisiológico
- Acelerometría
- Pruebas psicológicas
- Recolección de muestras de sangre
- Actigrafía
Otros números de identificación del estudio
- 09C525
- 55/25 (Otro identificador: Istituto Auxologico Italiano)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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