Recruiting

Circadian Reset Technology

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06858774

Conditions

Binge-Eating Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Circadian Reset Technology

VR Headset

Study Details

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.

Conditions

Binge-Eating Disorder

Study ID

NCT06858774

Start date

May 13, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

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.

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.

Primary outcome measure

  • Change in the total number of bulimic episodes [ Time Frame: Baseline to 1-month ]

Central Contacts and Locations

Central contacts

Tom Hildebrandt

212-659-8673tom.hildebrandt@mssm.edu

Jessica Bibeau

212-659-8673jessica.bibeau@mssm.edu

Locations

Department of Psychiatry, Eating and Weight Disorders Program

Recruiting

New York, New York, United States, 10028

Contacts

Jessica Bibeau

jessica.bibeau@mssm.edu

Principal Investigator:

Tom Hildebrandt

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Binge Eating Disorder
  • Eating Disorder
  • Eating Disorder Treatment
  • Circadian Rhythm Technology
  • Virtual Reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-04-20.