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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 18+

Diagnosed with Binge Eating Disorder using EDA-5

English-speaking

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Circadian Reset TechnologyExperimental treatment 1 intervention
Group B: VR HeadsetSham comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to 1-month

Secondary outcomes

1

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.

Time frame
Baseline to 1-month
2

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.

Time frame
Baseline to 1-month
3

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.

Time frame
Baseline to 1-month
4

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

Time frame
Baseline to 1-month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.