VR circadian reset to change REM sleep and reduce binge eating

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.