Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients With Binge Eating Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Circadian Reset Technology, VR Headset.
- Who it may be relevant to
- Registry conditions: Binge-Eating Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control Through Improved Network Connectivity in Brain in Patients With Binge Eating Disorder
Overview
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- Change in the total number of bulimic episodes [Time frame: Baseline to 1-month]
Secondary outcome measures (7)
- Change in Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline to 1-month]
- Change in Three-Factor Eating Questionnaire (TFEQ) [Time frame: Baseline to 1-month]
- Changes in default mode network [Time frame: Baseline to 1-month]
- Change in Eating Loss of Control Scale (ELOCS) [Time frame: Baseline to 1-month]
- Change in Food Cravings Questionnaire-Trait (FCQ-T) [Time frame: Baseline to 1-month]
- Change in Food Cravings Questionnaire-State (FCQ-S) [Time frame: Baseline to 1-month]
- Change in Depression Anxiety and Stress Scale (DASS) [Time frame: Baseline to 1-month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Department of Psychiatry, Eating and Weight Disorders Program — New York
Identifiers
NCT: NCT06858774 · STUDY-24-01454