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

Trial Summary

What is the purpose of this trial?

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 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.

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 data supports the effectiveness of the treatment Circadian Reset Technology for Binge Eating Disorder?

Research suggests that regulating circadian rhythms, such as through bright light therapy, can help reduce binge eating behaviors. This is because circadian disruptions are linked to eating disorders, and treatments that align these rhythms may improve symptoms. ^{1 2 3 4 5}

Is Circadian Reset Technology safe for humans?

The studies reviewed do not provide specific safety data for Circadian Reset Technology, but they suggest that interventions aimed at regulating circadian rhythms, such as bright light exposure, are generally considered safe and may improve sleep quality and mood in individuals with binge eating disorders. ^{1 2 3 6 7}

How does Circadian Reset Technology treatment differ from other treatments for binge eating disorder?

Circadian Reset Technology is unique because it focuses on aligning the body's natural 24-hour rhythms to improve eating behaviors, unlike traditional treatments that may not address these rhythms. This approach may involve interventions like bright light therapy to help regulate the timing of hunger and reduce binge eating episodes. ^{1 2 3 4 8}

Research Team

Tom Hildebrandt

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

The multidisciplinary therapy in binge eating disorder is able to influence the interdaily stability and sleep quality? [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A biobehavioral circadian model of restrictive eating and binge eating. [2022]

3. United States 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. [2023]

4. Turkey pubmed.ncbi.nlm.nih.gov

Feeding and Eating Disorders in the Context of Circadian Rhythms. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Disordered eating and obesity: associations between binge-eating disorder, night-eating syndrome, and weight-related comorbidities. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Rest-activity circadian rhythm and sleep quality in patients with binge eating disorder. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A matter of time: A systematic scoping review on a potential role of the circadian system in binge eating behavior. [2023]