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

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ClinicalTrials.gov Identifier: NCT03094260
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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).

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Device: High intensity bright light therapy Device: Low intensity light therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : October 29, 2021
Estimated Study Completion Date : October 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: High intensity light therapy
Treatment with light therapy in high intensity (10,000 lux)
Device: High intensity bright light therapy

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.


Placebo Comparator: Low intensity light therapy
Treatment with light therapy in low intensity (<500 lux)
Device: Low intensity light therapy

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.





Primary Outcome Measures :
  1. Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment [ Time Frame: Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0) ]
    The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day


Secondary Outcome Measures :
  1. Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment [ Time Frame: Day-7 to Day-1 period compared to Day23 to Day30 period ]
    The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day

  2. Characteristics of hyperphagic access (severity of the disorder) [ Time Frame: Day 0 ]
    Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.

  3. Characteristics of hyperphagic access (severity of the disorder) [ Time Frame: Day 30 ]
    Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.

  4. Characteristics of hyperphagic access (severity of the disorder) [ Time Frame: Day 60 ]
    Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.

  5. Characteristics of hyperphagic access (duration of crisis) [ Time Frame: Day 0 ]
    Evaluation of the duration,by the crisis agenda.

  6. Characteristics of hyperphagic access (duration of crisis) [ Time Frame: Day 30 ]
    Evaluation of the duration,by the crisis agenda.

  7. Characteristics of hyperphagic access (duration of crisis) [ Time Frame: Day 60 ]
    Evaluation of the duration,by the crisis agenda.

  8. Characteristics of hyperphagic access (amount of food ingested ) [ Time Frame: Day 0 ]
    Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.

  9. Characteristics of hyperphagic access (amount of food ingested ) [ Time Frame: Day 30 ]
    Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.

  10. Characteristics of hyperphagic access (amount of food ingested ) [ Time Frame: Day 60 ]
    Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.

  11. Characteristics of hyperphagic access ( evolution of factors triggering) [ Time Frame: Day 0 ]
    Evaluation of the factors triggering by the "START" scale.

  12. Characteristics of hyperphagic access ( evolution of factors triggering) [ Time Frame: Day 30 ]
    Evaluation of the factors triggering by the "START" scale.

  13. Characteristics of hyperphagic access ( evolution of factors triggering) [ Time Frame: Day 60 ]
    Evaluation of the factors triggering by the "START" scale.

  14. Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering) [ Time Frame: Day 30 ]
    Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale. Evaluation of the duration, the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda. Evaluation of the factors triggering by the "START" scale.

  15. Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment [ Time Frame: Day-7 to Day-1 period (before Day 0) compared to Day53 to Day60 period (after Day 0) ]
    The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day

  16. Symptomatic development of BED [ Time Frame: Day 0 ]

    The symptomatic development of BED will be measured by evaluating :

    • The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire
    • The Body concerns based on the "Body sharpe" questionnaire
    • The Addiction to food from the Yale Food Addiction scale
    • The Diet-related impulsivity from the Three-Factor Eating Questionnaire

  17. Symptomatic development of BED [ Time Frame: Day 30 ]

    The symptomatic development of BED will be measured by evaluating the composite:

    • The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire
    • The Body concerns based on the "Body sharpe" questionnaire
    • The Addiction to food from the Yale Food Addiction scale
    • The Diet-related impulsivity from the Three-Factor Eating Questionnaire

  18. Symptomatic development of BED [ Time Frame: Day 60 ]

    The symptomatic development of BED will be measured by evaluating the composite:

    • The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire
    • The Body concerns based on the "Body sharpe" questionnaire
    • The Addiction to food from the Yale Food Addiction scale
    • The Diet-related impulsivity from the Three-Factor Eating Questionnaire

  19. Evolution of other psychological parameters related to BED [ Time Frame: Day 0 ]
    The evolution of other psychological parameters will be measured by evaluating the composite :the mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale

  20. Evolution of other psychological parameters related to BED [ Time Frame: Day 30 ]
    The evolution of other psychological parameters will be measured by evaluating the composite the mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale

  21. Evolution of other psychological parameters related to BED [ Time Frame: Day 60 ]
    The evolution of other psychological parameters will be measured by evaluating the composite mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale

  22. Evolution of attentional cognitive profiles and impulsivity [ Time Frame: Day 0 ]
    The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task

  23. Evolution of attentional cognitive profiles and impulsivity [ Time Frame: Day 30 ]
    The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task

  24. Evolution of attentional cognitive profiles and impulsivity [ Time Frame: Day 60 ]
    The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task

  25. Evolution of appetite for different categories of food [ Time Frame: Day 0 ]
    The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/

  26. Evolution of appetite for different categories of food [ Time Frame: Day 30 ]
    The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/

  27. Evolution of appetite for different categories of food [ Time Frame: Day 60 ]
    The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/

  28. Biological parameters may be impacted or mediated by part of the treatment efficiency [ Time Frame: Day 0 ]
    Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3

  29. Biological parameters may be impacted or mediated by part of the treatment efficiency [ Time Frame: Day 30 ]
    Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3

  30. Weight (kilogramm) [ Time Frame: Day 0 ]
    Weight will be expressed in absolute value

  31. Weight (kilogramm) [ Time Frame: Day 30 ]
    Weight will be expressed in absolute value

  32. Weight (kilogramm) [ Time Frame: Day 60 ]
    Weight will be expressed in absolute value

  33. Observance rate to light therapy [ Time Frame: day1 to day30 ]
    The assessment of the adherence rate will be quantified by the average number of lux received over the 30 days of treatment. The exposure (expressed in lux number / session) in lux will be measured and recorded using a luxmeter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094260


Contacts
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Contact: Diane MORFIN, MD 4 27 85 60 11 ext +33 diane.morfin@chu-lyon.fr
Contact: Dominique DELAUNAY 4.72.11.00.64 ext +33 Dominique.delaunay@chu-lyon.fr

Locations
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France
HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon) Recruiting
Bron, France, 69500
Contact: Diane MORFIN, MD    4.27.85.60.11 ext +33    diane.morfin@chu-lyon.fr   
Contact: Dominique DELAUNAY    4.72.11.00.64 ext +33    Dominique.delaunay@chu-lyon.fr   
Principal Investigator: Diane MORFIN, MD         
Sub-Investigator: Bérénice SEGRESTIN, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Diane MORFIN, MD Hospices Civils de Lyon Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03094260     History of Changes
Other Study ID Numbers: 69HCL16_0626
2016-A01768-43 ( Other Identifier: ID-RCB )
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms