Circadian Reset Technology for Binge Eating Disorder

Overseen By Jessica Bibeau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Pregnancy, Suicide risk, Good sleep, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether new virtual reality (VR) technology can assist people with binge eating disorder by improving sleep and controlling appetite. Participants will use a VR headset twice daily for a month. One group will use a special circadian reset technology (CRT), while the other will use a regular VR program as a control. Individuals diagnosed with binge eating disorder who feel their eating habits affect their daily life might be a good fit. The researchers hope that better sleep will lead to better control over eating habits. As an unphased trial, this study offers a unique opportunity to explore innovative technology that could enhance quality of life.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this circadian reset technology is safe for individuals with binge eating disorder?

Research shows that specific safety data for Circadian Reset Technology (CRT) is not yet available. However, CRT aims to help manage sleep patterns, which is generally safe. This trial involves using a VR headset for short daily sessions, likely making it easy to handle. Since CRT does not involve medication or medical procedures, it typically has fewer side effects. Participants in similar studies have not reported major problems. The use of VR and light in CRT is expected to be safe, but individuals sensitive to light or prone to motion sickness should exercise caution. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Circadian Reset Technology for treating Binge Eating Disorder because it leverages the body's internal clock to potentially regulate eating behaviors. Unlike standard treatments like cognitive behavioral therapy or medications that target neurotransmitters, this technology uses a non-invasive VR headset to influence circadian rhythms directly. The unique delivery method involves brief, twice-daily sessions that aim to reset the body's natural cycles, offering a novel, drug-free approach that could lead to improved outcomes with minimal side effects.

What evidence suggests that Circadian Reset Technology is effective for binge eating disorder?

Research shows that the body's internal clock, known as circadian rhythms, might be connected to binge eating disorder. Studies have found that individuals with this disorder often eat more and experience stronger food cravings at specific times of the day. In this trial, participants will use Circadian Reset Technology (CRT), designed to enhance these rhythms, potentially aiding in better sleep and control over eating habits. By using a VR headset with CRT software, the goal is to reduce binge eating by resetting these internal clocks. Early results suggest that improving sleep and rhythm regulation could lead to fewer binge eating episodes. ^{1 2 6 7 8}

Who Is on the Research Team?

Tom Hildebrandt

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with binge eating disorder. Participants will use a VR headset twice daily for a month. They must not have other conditions that could interfere with the study or be using treatments that affect sleep and eating behaviors.

Inclusion Criteria

English-speaking

Diagnosed with Binge Eating Disorder using EDA-5

Exclusion Criteria

Pregnancy

Acute suicide risk/active suicidal ideation

PSQI score <5 indicating good sleep quality

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants use a VR headset twice daily for 5 minutes each session over 1 month. Weekly online surveys and daily EMA surveys are conducted.

4 weeks

Weekly online surveys, daily EMA surveys

Follow-up

Participants are monitored for changes in binge eating frequency, sleep quality, and other secondary outcomes.

4 weeks

1 visit (in-person) for final assessments

What Are the Treatments Tested in This Trial?

Interventions

• Circadian Reset Technology

Trial Overview The study tests if circadian reset technology (CRT) via a VR headset can reduce binge eating by improving sleep quality and control over appetite. Half of the participants will use CRT, while the other half will use a control software.

How Is the Trial Designed?

Group I: Circadian Reset Technology Experimental Treatment 1 Intervention

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 II: VR Headset Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Individuals with eating disorders often experience disrupted eating rhythms, characterized by delayed mealtime peaks and atypical hunger patterns, which may lead to binge-eating episodes later in the day.

The proposed biobehavioral circadian model suggests that circadian disruptions play a significant role in the development and maintenance of restrictive and binge eating behaviors, indicating that interventions aimed at regulating circadian rhythms could enhance the effectiveness of existing eating disorder treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A biobehavioral circadian model of restrictive eating and binge eating. De Young, KP., Bottera, AR.[2022]

In a pilot study involving 22 adults with binge-eating disorder (BED), the combination of naltrexone and bupropion (NB) was well-tolerated, showing significant reductions in binge-eating frequency, eating-disorder psychopathology, depression, and weight during treatment, although these effects were not significantly different from placebo.

Notably, 45.5% of patients on NB achieved a 3% weight loss compared to none on placebo, indicating a potential benefit of NB for weight management in BED, but further research with a larger sample size is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Grilo, CM., Lydecker, JA., Morgan, PT., et al.[2022]

Women with Binge Eating Disorder (BED) showed significant differences in their circadian rhythm compared to a control group, with reduced MESOR and Amplitude, but improved sleep quality after undergoing a structured multidisciplinary therapy.

The study, which included 28 women (14 with BED and 14 controls) monitored over 5 days, found that the BED group had better synchronization of their rest-activity rhythms and higher sleep efficiency, suggesting that a regular lifestyle can positively impact sleep patterns in patients with eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The multidisciplinary therapy in binge eating disorder is able to influence the interdaily stability and sleep quality? Galasso, L., Montaruli, A., Mulè, A., et al.[2020]

Misalignment of food intake with our natural circadian rhythms can lead to serious health issues like obesity and disordered eating, particularly in evening-type individuals who tend to skip meals and eat late at night.

Chronotherapeutic interventions, such as bright light therapy, show promise in reducing disordered eating behaviors, but more research is needed to fully understand their effects on metabolic disorders and obesity-related eating issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding and Eating Disorders in the Context of Circadian Rhythms. Kandeğer, A., Eğilmez, Ü., Selvi, Y.[2022]

In a study involving 34 females with binge-eating disorder and bulimia nervosa, morning bright light exposure significantly reduced binge eating and food preoccupation for those with high dietary restraint and negative affect.

These results suggest that morning bright light could be an effective complementary treatment for individuals with binge-spectrum eating disorders, particularly for those who are harder to treat due to their specific psychological profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses to bright light exposure in individuals with binge-spectrum eating disorders characterized by high dietary restraint and negative affect. Kambanis, PE., Bottera, AR., De Young, KP.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06858774?cond=%22Binge-Eating%20Disorder%22&aggFilters=status:not%20rec&rank=1

Use of Circadian Reset Technology to Alter REM Sleep ... This project includes testing circadian reset technology (CRT) on frequency of binge eating in a sample of 40 individuals with binge eating disorder.

2. trialx.com trialx.com/clinical-trials/listings/318389/use-of-circadian-reset-technology-to-alter-rem-sleep-and-appetitive-control-in-patients-with-binge-eating-disorder/

Use of Circadian Reset Technology to Alter REM Sleep ... This project includes testing circadian reset technology (CRT) on frequency of binge eating in a sample of 40 individuals with binge eating ...

3. withpower.com withpower.com/trial/phase-bulimia-2-2025-17fdf

Circadian Reset Technology for 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9352861/

Is the binge-eating disorder a circadian disorder? - PMC Only a few studies report circadian preferences in patients with eating disorders (37, 40, 45). A circadian approach to the BED indicated that ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.978412/full

A matter of time: A systematic scoping review on a potential ... Evidence from these studies suggests that individuals with BE behavior tend to have more food intake, more binge cravings, and more BE episodes ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06858774/use-of-circadian-reset-technology-to-alter-rem-sleep-and-appetitive-control-in-patients-with-binge-eating-disorder

Use of Circadian Reset Technology to Alter REM Sleep ... Examine whether 1-month of CRT alters binge eating frequency. Secondary outcomes include examining whether 1-month of CRT alters sleep quality, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12336790/

Integrating Artificial Intelligence and Smartphone Technology ... Efforts to understand the role of sensor‐derived data in predicting eating disorder outcomes do exist, though studies have predominantly used non‐smartphone‐ ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1471015325000194

Associations between intraindividual variability in weekday ... Greater mean duration of sleep was associated with lower odds of screening positive for an eating disorder in both models. Results are consistent with theories ...