Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-30 @ 9:42 PM
Study NCT ID:
NCT06271304
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants are instructed not to discuss the appearance of their designated eyewear with their care providers or the investigator or outcome assessor. Participants are not informed of the exact filtration level of their eyewear.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Outcome assessors will be blinded to the treatment assignment. At the beginning of each assessment, participants will be instructed not to describe or discuss their glasses with the assessor. Because the two types of glasses are of different color (clear (LF) and orange (BB)), we cannot guarantee a full blinding of the participants. Participants will be informed that we are studying the effects of two different types of light filters without more detail so they will not be provided with certain knowledge of which condition is expected to yield the largest effect. We will assess the integrity of the blind by asking participants whether they think they received glasses with high or low filtration lenses at the end of the study. Participants will be discouraged from actively seeking information about sleep glasses during the study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manic symptoms', 'timeFrame': '7 days', 'description': 'Change in Young Mania Rating Scale Score, range 0-60, higher scores indicating greater manic symptom load'}], 'secondaryOutcomes': [{'measure': 'Mood instability', 'timeFrame': '15 weeks', 'description': 'Change in day-to-day variation in electronically self-monitored mood scores'}, {'measure': 'Objective sleep quality', 'timeFrame': '7 days', 'description': 'Actigraphic measures of sleep latency, sleep time, efficiency and wake periods'}, {'measure': 'Objective sleep quality', 'timeFrame': '15 weeks', 'description': 'Actigraphic measures of sleep latency, sleep time, efficiency and wake periods'}, {'measure': 'Subjective sleep quality', 'timeFrame': '7 days', 'description': 'change in sleep scores from a modified version of the Pittsburgh Sleep Quality Index, range 0-21, higher scores indicating worse sleep quality'}, {'measure': 'Subjective sleep quality', 'timeFrame': '15 weeks', 'description': 'change in sleep scores from a modified version of the Pittsburgh Sleep Quality Index, range 0-21, higher scores indicating worse sleep quality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.\n\nWhen in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days.\n\nAfter this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime).', 'detailedDescription': 'The study is a 2-arm single-blind RCT to assess the effects of blue blocking (BB) or clear glasses as an acute 7-day antimanic intervention and as a 3-month mood stabilizing maintenance intervention. BB or clear glasses will be applied in addition to outpatient TAU for BD. Participants will be recruited among patients treated for BD in specialized outpatient clinics within the Mental Health Center Copenhagen.\n\nThe active intervention is BB-glasses that eliminate 99 % of light with a wavelength below 530 nm, whereas the clear glasses filter out only 15% of short wavelength light (low filtration (LF).\n\nParticipation includes 3 months use of the designated eyewear along with daily electronic self-monitoring of mood, sleep and activity as well as participation in a 2-day baseline assessment and a total of 3 follow-up visits including clinical assessment interview, questionnaires, and actigraphic (48 hours) and pupillometric assessments at day 9, week 5 and week 15.\n\nParticipants will be included during hypomanic or manic state and begin treatment with an antimanic dosage of 14 hours (6 PM - 8 AM) for 7 consecutive days. Subsequently, during the 3-month follow-up period, the dosage (hours using the glasses) can be adjusted according to the current state, with use for 14 hours during hypomanic/manic phases and 2 hours before bedtime during euthymic and depressive states.\n\nOutcome assessors will be blinded to the treatment assignment and patients will be informed that they are randomized to eyewear with either high or low filtration of light. Patients will be randomized on a 1:1 basis with stratification according to sex and outpatient clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of bipolar disorder\n* YMRS-score \\>13\n* Age 18-60 years\n* Speaks and writes Danish at a level equal to mother tongue\n\nExclusion Criteria:\n\n* Not willing or able to adhere to the protocol\n* Severe eye disorder or eye trauma\n* Treatment with betablockers\n* Sleep disturbances not related to BD (e.g, sleep apnea, restless legs syndrome) • • Substance abuse\n* Unwilling to use the electronic self-monitoring system, the Monsenso system\n* Prior/current use of BB glasses\n* Current/planned pregnancy\n* Night shift work\n* Suicidality'}, 'identificationModule': {'nctId': 'NCT06271304', 'acronym': 'BLUES', 'briefTitle': 'Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Mental Health Services in the Capital Region, Denmark'}, 'officialTitle': 'Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder', 'orgStudyIdInfo': {'id': 'BLUES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blue blocking glasses (BB)', 'description': 'Eyewear with orange-tinted lenses that block 99% of short wavelength visible light \\< 500 nm', 'interventionNames': ['Device: Blue blocking eyewear']}, {'type': 'SHAM_COMPARATOR', 'label': 'Low filtration glasses (LF)', 'description': 'Eyewear with clear lenses that block 15% of short wavelength light \\< 500 nm', 'interventionNames': ['Device: Low filtration eyewear']}], 'interventions': [{'name': 'Blue blocking eyewear', 'type': 'DEVICE', 'description': 'Eyewear is worn daily from 6 PM to 8 AM during manic/hypomanic state Eyewear is worn daily 2 hours before planned bedtime during euthymic, depressive and mixed state', 'armGroupLabels': ['Blue blocking glasses (BB)']}, {'name': 'Low filtration eyewear', 'type': 'DEVICE', 'description': 'Eyewear is worn daily from 6 PM to 8 AM during manic/hypomanic state Eyewear is worn daily 2 hours before planned bedtime during euthymic, depressive and mixed state', 'armGroupLabels': ['Low filtration glasses (LF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lars V Kessing, Professor', 'role': 'CONTACT', 'email': 'lars.vedel.kessing@regionh.dk', 'phone': '38647081', 'phoneExt': '0045'}, {'name': 'Maria Faurholt-Jepsen, MD, DMSc', 'role': 'CONTACT', 'email': 'maria.faurholtjepsen@regionh.dk', 'phone': '38647073', 'phoneExt': '0045'}], 'facility': 'Psychiatric Center Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Helle Madsen, MD', 'role': 'CONTACT', 'email': 'helle.oestergaard.madsen@regionh.dk', 'phone': '38 64 70 81'}], 'overallOfficials': [{'name': 'Lars Kessing', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mental Health Center Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}