VR circadian reset to change REM sleep and reduce binge eating
Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control Through Improved Network Connectivity in Brain in Patients With Binge Eating Disorder
NA · Icahn School of Medicine at Mount Sinai · NCT06858774
This trial uses a VR-based circadian reset program to try to reduce binge-eating episodes in adults with binge-eating disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06858774 on ClinicalTrials.gov |
What this trial studies
Forty adults with diagnosed binge-eating disorder will be randomized to use a VR headset twice daily for one month with either circadian reset technology (CRT) software or a control software. Each VR session is 5 minutes on waking and 5 minutes before sleep, with baseline, weekly, daily EMA, and a 1-month follow-up including repeat measures and fMRI. Primary outcome is change in binge eating frequency; secondary outcomes include sleep quality, appetite regulation, food craving/impulsivity, mood, and fMRI functional connectivity. All recruitment, device setup, and key visits (including the fMRI) are conducted through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai.
Who should consider this trial
Good fit: Adults 18 or older with a confirmed diagnosis of binge-eating disorder who are English-speaking, have at least some sleep disturbance, and have no medical/vestibular conditions that make VR unsafe are ideal candidates.
Not a fit: People with good baseline sleep (PSQI <5), pregnancy, active suicidal ideation, or medical conditions that increase VR risk (seizure risk, unstable cardiac disease, significant vision or inner-ear problems) would be unlikely to benefit or be ineligible.
Why it matters
Potential benefit: If successful, this non-drug approach could reduce binge-eating episodes by improving sleep and appetitive control.
How similar studies have performed: Light- and circadian-based interventions have shown promise for sleep and mood, but using VR-delivered circadian reset specifically to reduce binge eating is largely novel and not well tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Department of Psychiatry, Eating and Weight Disorders Program — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Tom Hildebrandt — Icahn School of Medicine at Mount Sinai
- Study coordinator: Tom Hildebrandt
- Email: tom.hildebrandt@mssm.edu
- Phone: 212-659-8673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Binge-Eating Disorder, Binge Eating Disorder, Eating Disorder, Eating Disorder Treatment, Circadian Rhythm Technology, Virtual Reality