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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06858774
Status
Recruiting
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Conditions

  • Binge-Eating Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Circadian Reset Technology — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 13, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Psychiatry, Eating and Weight Disorders ProgramNew YorkNew York10028
Jessica Bibeau
[email protected]
Tom Hildebrandt (PRINCIPAL_INVESTIGATOR)

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By research site
Department of Psychiatry, Eating and Weight Disorders Program· New York, NY

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