NCT06858774

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

Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control Through Improved Network Connectivity in Brain in Patients With Binge Eating Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Binge-Eating Disorder

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-05-13
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-03-05
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States