Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT04612192
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light Therapy for Chronic Insomnia in General Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D021081', 'term': 'Chronobiology Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2020-10-30', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of sleep efficiency between active and placebo light condition', 'timeFrame': 'Before light therapy', 'description': 'ratio of total sleep time on total time in bed in measured with actimetry'}, {'measure': 'Difference of sleep efficiency between active and placebo light condition', 'timeFrame': 'After 4 weeks of light therapy', 'description': 'ratio of total sleep time on total time in bed measured with actimetry'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia Chronic', 'Sleep Disorder', 'Circadian Rhythm Disorders']}, 'descriptionModule': {'briefSummary': '* Sleep disorders, especially insomnia\n* Attention deficits (or disorders), daytime somnolence and drug dependence\n* The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice', 'detailedDescription': 'Insomnia affects 15 to 20% of the general French adult population and increases with age. General practitioners (GPs) are the first confronted to sleep disorders, especially insomnia.\n\nCognitive-behavioral therapies (CBT) have proven effective, but their implementation in everyday practice is limited, and alternative treatments are still needed.\n\nLight not only has a great influence on the sleep-wake cycle and alertness, but also on mood and cognitive functions.\n\nThe administration time of light condition will be calculated for each individual in a modality that has no impact on the circadian phase.\n\nStudy will be conduct on an outpatient basis in general practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'randomisation by sex', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complaining of chronic insomnia according to ICSD-3 (International Classification of Sleep Disorders) criteria and/or taking hypnotics at least 3 nights per week for more than 3 months.\n* Non-hypnotic medication: stable medication during one month preceding the inclusion and for the 8 weeks of the study.\n* Compliance with the treatment: the patient is able to have light therapy during the required time and at the agreed schedule.\n\nExclusion Criteria:\n\n* Severe psychiatric disorder (severe major depression, schizophrenia, bipolar disorder), obvious acute psychiatric comorbidity.\n* Untreated intrinsic sleep pathology: sleep apnea syndrome based on clinical criteria: STOP-BANG questionnaire score, restless legs syndrome manifesting more than 2 times a week and/or requiring treatment.\n* Mild to severe dementia.\n* Neurodegenerative sleep troubles\n* Severe intercurrent pathology.\n* Ophthalmic troubles presenting a contraindication to light therapy: retinopathy, age-related macular degeneration, diabetic retinopathy, macular hole, epiretinal membrane); lens opacifications (cataract) justifying surgery (correction of poor visual acuity, visual discomfort); glaucomatous and non-glaucomatous optic neuropathy resulting in visual impairement.\n* Toxicomania, chronic alcoholism.\n* Secondary insomnia linked to somatic non-stabilized pathology.\n* Elements influencing circadian rhythm\n* Pregnancy, breastfeeding.\n* Participation in another interventional clinical trial which includes an exclusion period\n* No information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.)\n* Patient under guardianship\n* Non hypnotic treatment potentially inducing a level 3 sleepiness one week before'}, 'identificationModule': {'nctId': 'NCT04612192', 'acronym': 'Insolux', 'briefTitle': 'Light Therapy for Chronic Insomnia in General Practice', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study', 'orgStudyIdInfo': {'id': '7348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active light', 'description': 'Active light', 'interventionNames': ['Device: Active luminette']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo light', 'description': 'Placebo light', 'interventionNames': ['Device: Placebo luminette']}], 'interventions': [{'name': 'Active luminette', 'type': 'DEVICE', 'description': 'receive an active light using glasses of 1500 lux (an average of 180 photons/s/cm2, with a maximum wavelenght at 468 nm), 30-minute long light therapy in the morning, in a time period defined by sleep log and chronotype questionnaire, on a 4-week period', 'armGroupLabels': ['Active light']}, {'name': 'Placebo luminette', 'type': 'DEVICE', 'description': 'receive a placebo light using glasses (an average of n photons/s/cm2, single- band spectrum with a narrow peak at 660 nm under 50 lux), with the same modality as the experimental group', 'armGroupLabels': ['Placebo light']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44210', 'city': 'Nantes', 'country': 'France', 'facility': 'University of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'CHU Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}