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

NCT06858774 | Recruiting

• 1 other identifier: STUDY-24-01454
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder

Keywords

Binge Eating Disorder; Eating Disorder; Eating Disorder Treatment; Circadian Rhythm Technology; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Change in the total number of bulimic episodes

  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 Outcomes (7)

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline to 1-month

• Change in Three-Factor Eating Questionnaire (TFEQ)

  Baseline to 1-month

• Changes in default mode network

  Baseline to 1-month

• Change in Eating Loss of Control Scale (ELOCS)

  Baseline to 1-month

• Change in Food Cravings Questionnaire-Trait (FCQ-T)

  Baseline to 1-month

Study Arms (2)

Circadian Reset Technology

EXPERIMENTAL

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

VR Headset

SHAM COMPARATOR

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

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.

Circadian Reset Technology

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.

VR Headset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18+
• Diagnosed with Binge Eating Disorder using EDA-5
• English-speaking

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Department of Psychiatry, Eating and Weight Disorders Program

New York, New York, 10028, United States

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tom Hildebrandt

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Hildebrandt

CONTACT

212-659-8673; tom.hildebrandt@mssm.edu

Jessica Bibeau

CONTACT

212-659-8673; jessica.bibeau@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of the Division of Eating & Weight Disorders

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)