Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-07 @ 12:08 AM
Study NCT ID:
NCT03094260
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light Therapy and Binge Eating Disorder Treatment (BED Light Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment', 'timeFrame': 'Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)', 'description': 'The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day'}], 'secondaryOutcomes': [{'measure': 'Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment', 'timeFrame': 'Day-7 to Day-1 period compared to Day23 to Day30 period', 'description': 'The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day'}, {'measure': 'Characteristics of hyperphagic access (severity of the disorder)', 'timeFrame': 'Day 0', 'description': 'Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.'}, {'measure': 'Characteristics of hyperphagic access (severity of the disorder)', 'timeFrame': 'Day 30', 'description': 'Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.'}, {'measure': 'Characteristics of hyperphagic access (severity of the disorder)', 'timeFrame': 'Day 60', 'description': 'Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.'}, {'measure': 'Characteristics of hyperphagic access (duration of crisis)', 'timeFrame': 'Day 0', 'description': 'Evaluation of the duration,by the crisis agenda.'}, {'measure': 'Characteristics of hyperphagic access (duration of crisis)', 'timeFrame': 'Day 30', 'description': 'Evaluation of the duration,by the crisis agenda.'}, {'measure': 'Characteristics of hyperphagic access (duration of crisis)', 'timeFrame': 'Day 60', 'description': 'Evaluation of the duration,by the crisis agenda.'}, {'measure': 'Characteristics of hyperphagic access (amount of food ingested )', 'timeFrame': 'Day 0', 'description': 'Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.'}, {'measure': 'Characteristics of hyperphagic access (amount of food ingested )', 'timeFrame': 'Day 30', 'description': 'Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.'}, {'measure': 'Characteristics of hyperphagic access (amount of food ingested )', 'timeFrame': 'Day 60', 'description': 'Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.'}, {'measure': 'Characteristics of hyperphagic access ( evolution of factors triggering)', 'timeFrame': 'Day 0', 'description': 'Evaluation of the factors triggering by the "START" scale.'}, {'measure': 'Characteristics of hyperphagic access ( evolution of factors triggering)', 'timeFrame': 'Day 30', 'description': 'Evaluation of the factors triggering by the "START" scale.'}, {'measure': 'Characteristics of hyperphagic access ( evolution of factors triggering)', 'timeFrame': 'Day 60', 'description': 'Evaluation of the factors triggering by the "START" scale.'}, {'measure': 'Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)', 'timeFrame': 'Day 30', 'description': '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.'}, {'measure': 'Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment', 'timeFrame': 'Day-7 to Day-1 period (before Day 0) compared to Day53 to Day60 period (after Day 0)', 'description': 'The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day'}, {'measure': 'Symptomatic development of BED', 'timeFrame': 'Day 0', 'description': 'The symptomatic development of BED will be measured by evaluating :\n\n* The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire\n* The Body concerns based on the "Body sharpe" questionnaire\n* The Addiction to food from the Yale Food Addiction scale\n* The Diet-related impulsivity from the Three-Factor Eating Questionnaire'}, {'measure': 'Symptomatic development of BED', 'timeFrame': 'Day 30', 'description': 'The symptomatic development of BED will be measured by evaluating the composite:\n\n* The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire\n* The Body concerns based on the "Body sharpe" questionnaire\n* The Addiction to food from the Yale Food Addiction scale\n* The Diet-related impulsivity from the Three-Factor Eating Questionnaire'}, {'measure': 'Symptomatic development of BED', 'timeFrame': 'Day 60', 'description': 'The symptomatic development of BED will be measured by evaluating the composite:\n\n* The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire\n* The Body concerns based on the "Body sharpe" questionnaire\n* The Addiction to food from the Yale Food Addiction scale\n* The Diet-related impulsivity from the Three-Factor Eating Questionnaire'}, {'measure': 'Evolution of other psychological parameters related to BED', 'timeFrame': 'Day 0', 'description': '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'}, {'measure': 'Evolution of other psychological parameters related to BED', 'timeFrame': 'Day 30', 'description': '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'}, {'measure': 'Evolution of other psychological parameters related to BED', 'timeFrame': 'Day 60', 'description': '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'}, {'measure': 'Evolution of attentional cognitive profiles and impulsivity', 'timeFrame': 'Day 0', 'description': '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'}, {'measure': 'Evolution of attentional cognitive profiles and impulsivity', 'timeFrame': 'Day 30', 'description': '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'}, {'measure': 'Evolution of attentional cognitive profiles and impulsivity', 'timeFrame': 'Day 60', 'description': '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'}, {'measure': 'Evolution of appetite for different categories of food', 'timeFrame': 'Day 0', 'description': '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/'}, {'measure': 'Evolution of appetite for different categories of food', 'timeFrame': 'Day 30', 'description': '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/'}, {'measure': 'Evolution of appetite for different categories of food', 'timeFrame': 'Day 60', 'description': '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/'}, {'measure': 'Biological parameters may be impacted or mediated by part of the treatment efficiency', 'timeFrame': 'Day 0', 'description': 'Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3'}, {'measure': 'Biological parameters may be impacted or mediated by part of the treatment efficiency', 'timeFrame': 'Day 30', 'description': 'Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3'}, {'measure': 'Weight (kilogramm)', 'timeFrame': 'Day 0', 'description': 'Weight will be expressed in absolute value'}, {'measure': 'Weight (kilogramm)', 'timeFrame': 'Day 30', 'description': 'Weight will be expressed in absolute value'}, {'measure': 'Weight (kilogramm)', 'timeFrame': 'Day 60', 'description': 'Weight will be expressed in absolute value'}, {'measure': 'Observance rate to light therapy', 'timeFrame': 'day1 to day30', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Binge-Eating Disorder']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 55 years old\n* Binge eating disorders or other eating disorders according to DSM V criteria\n* Patient with BES score (with " Bing Eating Scale " ) \\> 18\n* Patient with BMI \\> 18.5 kg/m2\n* Patient who agrees to be included in the study and who signs the informed consent form\n* Patient affiliated to a healthcare insurance plan\n\nExclusion Criteria:\n\n* Patients with other psychiatric comorbidities, including a disorder bipolar mood\n* Unstabilized diabetic patient with or retinopathy\n* Patient with sleep disorder (delay or phase inversion)\n* Patient with psychotropic treatment unstabilized (except anxiolytic treatment)\n* Recent eye surgery or eye problem preventing exposure to bright light.\n* Medication making the skin more sensitive to light (eg. Tablets against malaria)\n* Patient who does not understand French/is unable to give consent\n* Mentally unbalanced patients, under supervision or guardianship\n* Patient already included in a research study\n* Pregnancy or desire to be pregnant during the study'}, 'identificationModule': {'nctId': 'NCT03094260', 'briefTitle': 'Light Therapy and Binge Eating Disorder Treatment (BED Light Study)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial', 'orgStudyIdInfo': {'id': '69HCL16_0626'}, 'secondaryIdInfos': [{'id': '2016-A01768-43', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity light therapy', 'description': 'Treatment with light therapy in high intensity (10,000 lux)', 'interventionNames': ['Device: High intensity bright light therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low intensity light therapy', 'description': 'Treatment with light therapy in low intensity (\\<500 lux)', 'interventionNames': ['Device: Low intensity light therapy']}], 'interventions': [{'name': 'High intensity bright light therapy', 'type': 'DEVICE', 'description': "Treatment with light therapy in high intensity (10,000 lux), daily for 30 days between 6 am and 9 am for 30 minutes.\n\nLe 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.", 'armGroupLabels': ['High intensity light therapy']}, {'name': 'Low intensity light therapy', 'type': 'DEVICE', 'description': "Treatment with light therapy in low intensity (\\<500 lux), daily for 30 days between 6 am and 9 am for 30 minutes.\n\nLe 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.", 'armGroupLabels': ['Low intensity light therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': "HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)", 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Diane MORFIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospices Civils de Lyon Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}