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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Using Virtual Reality and Sensor Technology to Enhance Outcomes From Treatment for Binge Eating

NCT05041660

Binge Eating Inhibition (Psychology)

COMPLETED NA

The Role of the Circadian System in Binge Eating Disorder

NCT04724668

Binge-Eating Disorder Circadian Rhythm Disorders

COMPLETED NA

A Pilot Test of Mood and Circadian Rhythm Mechanisms Driving Binge Eating

NCT03680989

Eating Disorder Binge Eating Circadian Dysregulation

COMPLETED NA

Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for Binge Eating Disorder

NCT06604299

Binge Eating Disorder

COMPLETED NA

Virtual Reality Based Cue-exposure Treatment for Bulimia Nervosa

NCT02237300

Bulimia Nervosa Binge-Eating Disorder Binge Eating

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Binge-Eating Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Phase II clinical trial testing CRT in 20 individuals with Binge Eating Disorder to determine if this technology alters eating behavior and sleep quality using 10 minutes of daily exposure for 1 month.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Randomization will take place in this study to assign participants to the stimulation condition (getting CRT or control). The randomization module in REDCap will be used to perform randomization placement. The study staff and participants will be blind to condition. Only the project manager will know which headsets have CRT and which are control, all other staff will be blind to designation in REDCap. As the use procedures are equivalent, problem solving set up or use can be done by staff without breaking blind as the interface and use are equivalent in each condition.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Circadian Reset Technology

Intervention Type 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

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.

Group Type SHAM_COMPARATOR

VR Headset

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Circadian Reset Technology

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.

Intervention Type BEHAVIORAL

VR Headset

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No