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Recruiting NCT06858774

NCT06858774 Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients With Binge Eating Disorder

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Clinical Trial Summary
NCT ID NCT06858774
Status Recruiting
Phase
Sponsor Icahn School of Medicine at Mount Sinai
Condition Binge-Eating Disorder
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2025-05-13
Primary Completion 2026-11

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Circadian Reset TechnologyVR Headset

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 40 participants in total. It began in 2025-05-13 with a primary completion date of 2026-11.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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.

Contact & Investigator

Central Contact

Tom Hildebrandt

✉ tom.hildebrandt@mssm.edu

📞 212-659-8673

Principal Investigator

Tom Hildebrandt

PRINCIPAL INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Frequently Asked Questions

Who can join the NCT06858774 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Binge-Eating Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06858774 currently recruiting?

Yes, NCT06858774 is actively recruiting participants. Contact the research team at tom.hildebrandt@mssm.edu for enrollment information.

Where is the NCT06858774 trial being conducted?

This trial is being conducted at New York, United States.

Who is sponsoring the NCT06858774 clinical trial?

NCT06858774 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Tom Hildebrandt at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 40 participants.

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