Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients with Binge Eating Disorder

Not Applicable

Not yet recruiting

• Conditions: Binge-Eating Disorder

• Registration Number: NCT06858774
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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 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.

Detailed Description

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, 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 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study Start: 2025-03
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Ages 18+
• Diagnosed with Binge Eating Disorder using EDA-5
• English-speaking

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the total number of bulimic episodes	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.

Secondary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index (PSQI)	Baseline to 1-month	Sleep quality measured by Pittsburgh Sleep Quality Index (PSQI) is a 19-item assessment that measures sleep quality with questions about duration, latency, frequency/severity of sleep issues. Items are answered on a scale of 0-3. The final score is a total of all questions ranging from 0 to 21 with lower score indicating worse sleep quality and higher score indicating better sleep quality. Scores will be calculated between baseline and 1 month.
Change in Three-Factor Eating Questionnaire (TFEQ)	Baseline to 1-month	Appetite regulation (restrained eating, disinhibited eating, and predisposition to hunger) measured by Three-Factor Eating Questionnaire (TFEQ) assesses appetite using 51 questions summarized in 3 subscales: cognitive restraint, uncontrolled eating, and emotional eating. Each item is scored as 0 or 1 and then summed. Subscales Cognitive restraint of eating score 0-21, Disinhibition score 0-16, and Hunger score 0-14. Full scale scored 0-51, higher scores indicate higher levels of restrained eating. Scores will be calculated between baseline and 1 month.
Changes in default mode network	Baseline to 1-month	Change in Brain functional connectivity as measured by default mode network - This test measures the pattern of connectivity in the default mode network during rest. Strength of connectivity DMN will estimated at the network level and between individual nodes.
Change in Eating Loss of Control Scale (ELOCS)	Baseline to 1-month	Food-based impulsivity measured by Eating Loss of Control Scale (ELOCS) measures the degree to which eating episodes included the feeling of loss of control measured continuously over the prior 4-weeks. There are 18 items scored on 0-10 scale from "not at all" to "Extremely/Completely". For total score, severity questions are averaged to get a mean severity score ranging between 0-10. Higher scores indicate more loss of control. Scores will be calculated between baseline and 1 month. Baseline to 1-month
Change in Food Cravings Questionnaire-Trait (FCQ-T)	Baseline to 1-month	Food-based cravings (Trait) measure by Food Cravings Questionnaire-Trait (FCQ-T) is 39 items on a scale of 1 (never/NA) to 6 (always) with a total summed score ranging from 39 to 234 with higher scores indicating more frequent and intense food cravings. Scores will be calculated between baseline and 1 month.
Change in Food Cravings Questionnaire-State (FCQ-S)	Baseline to 1-month	Food-based cravings (State) measured by Food Cravings Questionnaire-State (FCQ-S) has 15 items on a scale of 1 (strongly disagree) to 5 (strongly agree) with a total summed score ranging from 15 to 75 with higher scores indicating more intense food cravings. Scores will be calculated between baseline and 1 month.
Change in Depression Anxiety and Stress Scale (DASS)	Baseline to 1-month	Depression Anxiety and Stress Scale (DASS) includes 42 questions that assess negative mood using subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126, higher score indicates poorer health outcomes.; The depression scale scores are 0-9 (Normal), 10-13 (Mild), 14-20 (Moderate), 21-27 (Severe), and 28+ (Extremely Severe).; The anxiety scale scores are 0-7 (Normal), 8-9 (Mild), 10-14 (Moderate), 15-19 (Severe), and 20+ (Extremely Severe).; The stress scale scores are 0-14 (Normal), 15-18 (Mild), 19-25 (Moderate), 26-33 (Severe), and 34+ is (Extremely Severe).

Trial Locations

Locations (1)

Department of Psychiatry, Eating and Weight Disorders Program; 🇺🇸 New York, New York, United States