Light Therapy and Binge Eating Disorder Treatment (BED Light Study)

NCT03094260 | Completed

• 2 other identifiers: 69HCL16_06262016-A01768-43
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of BED by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (\<500 lux). Treatment will be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. Secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time Estimation Task, Switching Task), liking / wanted for different food categories and carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-OH vitamin D3).

Conditions

Binge-Eating Disorder

Outcome Measures

Primary Outcomes (1)

• Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment

  The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day

  Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)

Secondary Outcomes (33)

• Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment

  Day-7 to Day-1 period compared to Day23 to Day30 period

• Characteristics of hyperphagic access (severity of the disorder)

  Day 0

• Characteristics of hyperphagic access (severity of the disorder)

  Day 30

• Characteristics of hyperphagic access (severity of the disorder)

  Day 60

• Characteristics of hyperphagic access (duration of crisis)

  Day 0

Study Arms (2)

High intensity light therapy

EXPERIMENTAL

Treatment with light therapy in high intensity (10,000 lux)

Device: High intensity bright light therapy

Low intensity light therapy

PLACEBO COMPARATOR

Treatment with light therapy in low intensity (\<500 lux)

Device: Low intensity light therapy

Interventions

High intensity bright light therapy DEVICE

Treatment with light therapy in high intensity (10,000 lux), daily for 30 days between 6 am and 9 am for 30 minutes. Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subject is sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position.

High intensity light therapy

Low intensity light therapy DEVICE

Treatment with light therapy in low intensity (\<500 lux), daily for 30 days between 6 am and 9 am for 30 minutes. Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subjectis sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position.

Low intensity light therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 55 years old
• Binge eating disorders or other eating disorders according to DSM V criteria
• Patient with BES score (with " Bing Eating Scale " ) \> 18
• Patient with BMI \> 18.5 kg/m2
• Patient who agrees to be included in the study and who signs the informed consent form
• Patient affiliated to a healthcare insurance plan

You may not qualify if:

• Patients with other psychiatric comorbidities, including a disorder bipolar mood
• Unstabilized diabetic patient with or retinopathy
• Patient with sleep disorder (delay or phase inversion)
• Patient with psychotropic treatment unstabilized (except anxiolytic treatment)
• Recent eye surgery or eye problem preventing exposure to bright light.
• Medication making the skin more sensitive to light (eg. Tablets against malaria)
• Patient who does not understand French/is unable to give consent
• Mentally unbalanced patients, under supervision or guardianship
• Patient already included in a research study
• Pregnancy or desire to be pregnant during the study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)

Bron, 69500, France

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Diane MORFIN, MD

  Hospices Civils de Lyon Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 29, 2017
• Study Start: March 29, 2018
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)