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

Last updated: June 12, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bulimia

Binge Eating Disorder

Treatment

Circadian Reset Technology

VR Headset

Clinical Study ID

NCT06858774
STUDY-24-01454
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 18+

  • Diagnosed with Binge Eating Disorder using EDA-5

  • English-speaking

Exclusion

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 offalls, seizures, a heart condition, migraines, an eye or vision condition, or aninner ear condition.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Circadian Reset Technology
Phase:
Study Start date:
May 13, 2025
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • Department of Psychiatry, Eating and Weight Disorders Program

    New York, New York 10028
    United States

    Active - Recruiting

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