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

Mount Sinai Health System

Status: Enrolling

Conditions: Binge-Eating Disorder

Treatments: Behavioral: Circadian Reset Technology; Behavioral: VR Headset

Study type: Interventional

Funder types: Other

Identifiers

NCT06858774

STUDY-24-01454

Details and patient eligibility

About

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.

Full description

This is a clinical trial with total of 40 individuals with Binge Eating Disorder ages 18 or older will be enrolled to use a VR headset with CRT or without. Examine whether 1-month of CRT alters binge eating frequency. Secondary outcomes include examining whether 1-month of CRT alters sleep quality, appetite regulation, functional magnetic resonance imaging (fMRI) measures of functional connectivity, food-based impulsivity/craving, and mood. Assessments are completed at baseline, weekly for 1 month, and then a final 1-month follow-up. Procedures include a screening/baseline phase to determine eligibility, gather baseline measures, and set-up on VR headset. Weeks 1 through 4 include using a VR headset twice a day for 5 minutes each. An online weekly survey will be completed, as well as daily ecological momentary assessment (EMA) surveys related to eating patterns throughout each day. The final visit will include a repeat of the baseline procedures including the fMRI. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Circadian Reset Technology

Experimental group

Description:

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.

Treatment:

Behavioral: Circadian Reset Technology

VR Headset

Sham Comparator group

Description:

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.

Treatment:

Behavioral: VR Headset