Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control Through Improved Network Connectivity in Brain in Patients With Binge Eating Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the total number of bulimic episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization will take place in this study to assign participants to the stimulation condition (getting CRT or control). The randomization module in REDCap will be used to perform randomization placement. The study staff and participants will be blind to condition. Only the project manager will know which headsets have CRT and which are control, all other staff will be blind to designation in REDCap. As the use procedures are equivalent, problem solving set up or use can be done by staff without breaking blind as the interface and use are equivalent in each condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Binge Eating Disorder using EDA-5
- •English-speaking
排除标准
- •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.
研究组 & 干预措施
Circadian Reset Technology
Participants will be given the headset to use for 5 minutes twice a day for 1 month while sitting in a resting position. Use will be separated by 12-16 hours of wakefulness.
干预措施: Circadian Reset Technology (Behavioral)
VR Headset
Participants will be given a headset to use for 5 minutes twice a day for 1 month while sitting in a resting position. Use will be separated by 12-16 hours of wakefulness.
干预措施: VR Headset (Behavioral)
结局指标
主要结局
Change in the total number of bulimic episodes
时间窗: Baseline to 1-month
Binge eating frequency measured by Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q scores behavioral features of eating disorders by calculating the number of episodes and number of days on which the behavior occurs. The total number of bulimic episodes will be measured to determine binge-eating frequency. Scores will be calculated between baseline and 1 month. The EDE-Q is a 28-item self-report measure assessing eating disorder symptoms. Full scale from 0-6, with higher score indicates greater severity of eating disorder symptoms.
次要结局
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline to 1-month)
- Change in Three-Factor Eating Questionnaire (TFEQ)(Baseline to 1-month)
- Changes in default mode network(Baseline to 1-month)
- Change in Eating Loss of Control Scale (ELOCS)(Baseline to 1-month)
- Change in Food Cravings Questionnaire-Trait (FCQ-T)(Baseline to 1-month)
- Change in Food Cravings Questionnaire-State (FCQ-S)(Baseline to 1-month)
- Change in Depression Anxiety and Stress Scale (DASS)(Baseline to 1-month)
研究者
Tom Hildebrandt
Professor and Chief of the Division of Eating & Weight Disorders
Icahn School of Medicine at Mount Sinai