Clinical trial NCT06858774: Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients With Binge Eating Disorder
Official title: Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control Through Improved Network Connectivity in Brain in Patients With Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Binge-Eating Disorder
Keywords: Binge Eating Disorder
Eating Disorder
Eating Disorder Treatment
Circadian Rhythm Technology
Virtual Reality
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase II clinical trial testing CRT in 20 individuals with Binge Eating Disorder to determine if this technology alters eating behavior and sleep quality using 10 minutes of daily exposure for 1 month.
Primary purpose: TREATMENT

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 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.

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, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the total number of bulimic episodes
timeFrame: Baseline to 1-month
Secondary outcomes:
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to 1-month
measure: Change in Three-Factor Eating Questionnaire (TFEQ)
timeFrame: Baseline to 1-month
measure: Changes in default mode network
timeFrame: Baseline to 1-month
measure: Change in Eating Loss of Control Scale (ELOCS)
timeFrame: Baseline to 1-month
measure: Change in Food Cravings Questionnaire-Trait (FCQ-T)
timeFrame: Baseline to 1-month
measure: Change in Food Cravings Questionnaire-State (FCQ-S)
timeFrame: Baseline to 1-month
measure: Change in Depression Anxiety and Stress Scale (DASS)
timeFrame: Baseline to 1-month
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Psychiatry, Eating and Weight Disorders Program
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Tom Hildebrandt
role: PRINCIPAL_INVESTIGATOR
References: