Binge-Eating DisorderNCT06858774
Use of Circadian Reset Technology to Alter REM Sleep and Appetitive Control in Patients With Binge Eating Disorder
A study testing Circadian Reset Technology and VR Headset in people with Binge-Eating Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Circadian Reset Technology and VR Headset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18+
- Diagnosed with Binge Eating Disorder using EDA-5
- English-speaking
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, 10028
Jessica Bibeau, jessica.bibeau@mssm.edu
Tom Hildebrandt
About this study
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
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.
Read the 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.
- Conditions
- Binge-Eating Disorder
- Being tested
- Circadian Reset Technology, VR Headset
- Keywords
- Binge Eating Disorder, Eating Disorder, Eating Disorder Treatment, Circadian Rhythm Technology, Virtual Reality
- Medical subject headings
- Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Reset TechnologyBehavioural
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 HeadsetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: VR Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1-month
Secondary outcomes (7)
Change in Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline to 1-month
Change in Three-Factor Eating Questionnaire (TFEQ)
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.
Measured: Baseline to 1-month
Changes in default mode network
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.
Measured: Baseline to 1-month
Change in Eating Loss of Control Scale (ELOCS)
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
Measured: Baseline to 1-month
Change in Food Cravings Questionnaire-Trait (FCQ-T)
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.
Measured: Baseline to 1-month
Change in Food Cravings Questionnaire-State (FCQ-S)
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.
Measured: Baseline to 1-month
Change in Depression Anxiety and Stress Scale (DASS)
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).
Measured: Baseline to 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start13 May 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Hildebrandt, Icahn School of Medicine at Mount Sinai
- Investigators
- Tom Hildebrandt, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858774
- Sponsor's protocol ID
- STUDY-24-01454
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared from this trial due to the early stages of investigation.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06858774
- Acronym / sponsor ID
- STUDY-24-01454
- Conditions
- Binge-Eating Disorder
- Keywords
- Binge Eating Disorder, Eating Disorder, Eating Disorder Treatment, Circadian Rhythm Technology, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Circadian Reset Technology | Experimental | Behavioral: Circadian Reset TechnologyParticipants 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. |
| VR Headset | Sham comparator | Behavioral: VR HeadsetParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18+
- Diagnosed with Binge Eating Disorder using EDA-5
- English-speaking
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circadian Reset TechnologyCircadian 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. | Behavioural | Circadian Reset Technology |
| VR HeadsetThe 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. | Behavioural | VR Headset |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared from this trial due to the early stages of investigation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom Hildebrandt principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Reset Technology and VR Headset in people with Binge-Eating Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Hildebrandt (212-659-8673, tom.hildebrandt@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the total number of bulimic episodes (time frame: Baseline to 1-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.