Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients With Binge Eating Disorder
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Circadian Reset Technology, VR Headset.
- Кому может быть актуально
- Состояния в реестре: Binge-Eating Disorder. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control Through Improved Network Connectivity in Brain in Patients With Binge Eating Disorder
Обзор
This project includes testing circadian reset technology (CRT) on frequency of binge eating in a sample of 40 individuals with binge eating disorder. Participants will be randomized to one of two groups. Both groups use a virtual reality (VR) headset for 10 minutes (5 upon waking, 5 before sleep) daily for 1 month. One group will use the CRT software on the headset and the other group will use a software intended to be a control. Measures will be taken at baseline and 1-month. The researchers anticipate that use of CRT will improve sleep quality leading to increased appetitive control.
Подробное описание
This is a clinical trial with total of 40 individuals with Binge Eating Disorder ages 18 or older will be enrolled to use a VR headset with CRT or without. Examine whether 1-month of CRT alters binge eating frequency. Secondary outcomes include examining whether 1-month of CRT alters sleep quality, appetite regulation, functional magnetic resonance imaging (fMRI) measures of functional connectivity, food-based impulsivity/craving, and mood. Assessments are completed at baseline, weekly for 1 month, and then a final 1-month follow-up. Procedures include a screening/baseline phase to determine eligibility, gather baseline measures, and set-up on VR headset. Weeks 1 through 4 include using a VR headset twice a day for 5 minutes each. An online weekly survey will be completed, as well as daily ecological momentary assessment (EMA) surveys related to eating patterns throughout each day. The final visit will include a repeat of the baseline procedures including the fMRI. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai.
Вмешательства
- Поведенческое Circadian Reset Technology
Circadian reset technology is a software used on a VR headset in this intervention. The software is a passive viewing experience like a guided meditation that presents visual images. - Поведенческое VR Headset
The software used on a VR headset in this intervention is a passive viewing experience like a guided meditation that presents neutral images that mimics the sequence used in the CRT software.
Первичные конечные точки
- Change in the total number of bulimic episodes [Срок оценки: Baseline to 1-month]
Вторичные конечные точки (7)
- Change in Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline to 1-month]
- Change in Three-Factor Eating Questionnaire (TFEQ) [Срок оценки: Baseline to 1-month]
- Changes in default mode network [Срок оценки: Baseline to 1-month]
- Change in Eating Loss of Control Scale (ELOCS) [Срок оценки: Baseline to 1-month]
- Change in Food Cravings Questionnaire-Trait (FCQ-T) [Срок оценки: Baseline to 1-month]
- Change in Food Cravings Questionnaire-State (FCQ-S) [Срок оценки: Baseline to 1-month]
- Change in Depression Anxiety and Stress Scale (DASS) [Срок оценки: Baseline to 1-month]
Критерии участия
Критерии включения
- Ages 18+
- Diagnosed with Binge Eating Disorder using EDA-5
- English-speaking
Критерии исключения
- Pregnancy
- Acute suicide risk/active suicidal ideation
- PSQI score <5 indicating good sleep quality
- A condition that may create a risk while using the VR headset including risk of falls, seizures, a heart condition, migraines, an eye or vision condition, or an inner ear condition.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Department of Psychiatry, Eating and Weight Disorders Program — New York
Идентификаторы
NCT: NCT06858774 · STUDY-24-01454