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

April 15, 2026 updated by: Tom Hildebrandt, Icahn School of Medicine at Mount Sinai

Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control Through Improved Network Connectivity in Brain in Patients With Binge Eating Disorder

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10028
        • Recruiting
        • Department of Psychiatry, Eating and Weight Disorders Program
        • Principal Investigator:
          • Tom Hildebrandt
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the total number of bulimic episodes
Time Frame: Baseline to 1-month

Binge eating frequency measured by Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q scores behavioral features of eating disorders by calculating the number of episodes and number of days on which the behavior occurs. The total number of bulimic episodes will be measured to determine binge-eating frequency. Scores will be calculated between baseline and 1 month.

The EDE-Q is a 28-item self-report measure assessing eating disorder symptoms. Full scale from 0-6, with higher score indicates greater severity of eating disorder symptoms.
Baseline to 1-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline to 1-month
Sleep quality measured by Pittsburgh Sleep Quality Index (PSQI) is a 19-item assessment that measures sleep quality with questions about duration, latency, frequency/severity of sleep issues. Items are answered on a scale of 0-3. The final score is a total of all questions ranging from 0 to 21 with lower score indicating worse sleep quality and higher score indicating better sleep quality. Scores will be calculated between baseline and 1 month.
Baseline to 1-month
Change in Three-Factor Eating Questionnaire (TFEQ)
Time Frame: Baseline to 1-month
Appetite regulation (restrained eating, disinhibited eating, and predisposition to hunger) measured by Three-Factor Eating Questionnaire (TFEQ) assesses appetite using 51 questions summarized in 3 subscales: cognitive restraint, uncontrolled eating, and emotional eating. Each item is scored as 0 or 1 and then summed. Subscales Cognitive restraint of eating score 0-21, Disinhibition score 0-16, and Hunger score 0-14. Full scale scored 0-51, higher scores indicate higher levels of restrained eating. Scores will be calculated between baseline and 1 month.
Baseline to 1-month
Change in Eating Loss of Control Scale (ELOCS)
Time Frame: Baseline to 1-month
Food-based impulsivity measured by Eating Loss of Control Scale (ELOCS) measures the degree to which eating episodes included the feeling of loss of control measured continuously over the prior 4-weeks. There are 18 items scored on 0-10 scale from "not at all" to "Extremely/Completely". For total score, severity questions are averaged to get a mean severity score ranging between 0-10. Higher scores indicate more loss of control. Scores will be calculated between baseline and 1 month. Baseline to 1-month
Baseline to 1-month
Change in Food Cravings Questionnaire-Trait (FCQ-T)
Time Frame: Baseline to 1-month
Food-based cravings (Trait) measure by Food Cravings Questionnaire-Trait (FCQ-T) is 39 items on a scale of 1 (never/NA) to 6 (always) with a total summed score ranging from 39 to 234 with higher scores indicating more frequent and intense food cravings. Scores will be calculated between baseline and 1 month.
Baseline to 1-month
Change in Food Cravings Questionnaire-State (FCQ-S)
Time Frame: Baseline to 1-month
Food-based cravings (State) measured by Food Cravings Questionnaire-State (FCQ-S) has 15 items on a scale of 1 (strongly disagree) to 5 (strongly agree) with a total summed score ranging from 15 to 75 with higher scores indicating more intense food cravings. Scores will be calculated between baseline and 1 month.
Baseline to 1-month
Change in Depression Anxiety and Stress Scale (DASS)
Time Frame: Baseline to 1-month

Depression Anxiety and Stress Scale (DASS) includes 42 questions that assess negative mood using subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126, higher score indicates poorer health outcomes.

The depression scale scores are 0-9 (Normal), 10-13 (Mild), 14-20 (Moderate), 21-27 (Severe), and 28+ (Extremely Severe).

The anxiety scale scores are 0-7 (Normal), 8-9 (Mild), 10-14 (Moderate), 15-19 (Severe), and 20+ (Extremely Severe).

The stress scale scores are 0-14 (Normal), 15-18 (Mild), 19-25 (Moderate), 26-33 (Severe), and 34+ is (Extremely Severe).
Baseline to 1-month
Changes in default mode network
Time Frame: Baseline to 1-month
Change in Brain functional connectivity as measured by default mode network - This test measures the pattern of connectivity in the default mode network during rest. Strength of connectivity default mode network (DMN) will estimated at the network level and between individual nodes.
Baseline to 1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Tom Hildebrandt, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-24-01454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared from this trial due to the early stages of investigation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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