Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT05463302
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2022-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'participants receive two similar blankets, while one of them is real and one is sham but they are blind to which one is which.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'it is two period design with one cross over'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2022-07-12', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality measure', 'timeFrame': 'Through study completion, 2 years approximately', 'description': 'The change in the value of Odds of the Product (ORP) from baseline line to post-intervention, measured by the Prodigy device which is a combination of the EEG band waves. ORP is only one value output of the device.'}], 'secondaryOutcomes': [{'measure': 'heart rate variability', 'timeFrame': 'Through study completion, 2 years approximately', 'description': 'the change in heart rate variability (HRV) measured from beat to beat R-R interval.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electromagnetic field effect', 'sleep quality', 'EMF blocker'], 'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': "Exposure to electromagnetic field (EMF) emitted by mobile phones and devices with WIFI is on the rise and so is the EMF effects on sleep quality and well-being of individuals with high exposures to EMF. Some studies have shown poor sleep quality among individuals with long-term occupational exposure to EMF, and some have shown association between EMF long-term exposure and neuropsychiatric disorders including depression. This study aims to investigate a commercially available EMF- blocker blanket, called Sleepgift, that claims helping people to have a better sleep and improved health. We will investigate the Sleepgift efficacy on adults' quality of sleep and their vital signals as a measure of their well-being in a placebo-controlled single- blind cross-over designed study. Participants will sleep in our sleep lab at baseline and then 10 days later with the Sleepgift blanket after using it every night for the past 10 consecutive days. Participants will be given two blankets for each cycle of the study as it is a cross-over designed study: one Sleepgift and one regular blanket; they will not know which one is real or sham. There will be one-month washout period between the two cycles of the cross-over study. We aim to enroll 30 adults for the study. Participants' sleep quality will be measured by the established device called Prodogy; their vital signals will also be measured and monitored through the night. The collected data will be analyzed statistically for any significant effect of the Sleepgift blanket on sleep quality and vital signals such as heart's rhythm and heart rate variability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 y\\<age\\<70 years\n* Being generally healthy (cognitively and psychologically)\n* ability to read, write and speak English fluently.\n\nExclusion Criteria:\n\n* Being diagnosed with any neurological, intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder.\n* Inability to adequately communicate in English\n* Current substance abuse disorder\n* Currently participating in another therapeutic study\n* Being on a regular pain killer, sleeping or depression pill.'}, 'identificationModule': {'nctId': 'NCT05463302', 'briefTitle': 'Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health', 'orgStudyIdInfo': {'id': 'Sleep Gift Blanket'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active EMF blanket', 'description': 'participants will receive the real EMF blocker blanket', 'interventionNames': ['Device: Active sleepgift blanket', 'Device: Sham Sleepgift Blanket']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham EMF blanket', 'description': 'participants will receive the sham EMF blocker blanket', 'interventionNames': ['Device: Active sleepgift blanket', 'Device: Sham Sleepgift Blanket']}], 'interventions': [{'name': 'Active sleepgift blanket', 'type': 'DEVICE', 'description': 'Participants for group1 will be provided with real/active sleepgift blanket first for 10 consecutive nights and then cross over.', 'armGroupLabels': ['Active EMF blanket', 'Sham EMF blanket']}, {'name': 'Sham Sleepgift Blanket', 'type': 'DEVICE', 'description': 'Participants for group 2 will be provided with sham sleepgift blanket for 10 consecutive nights and then cross over.', 'armGroupLabels': ['Active EMF blanket', 'Sham EMF blanket']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3L 2P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Riverview Health Center', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Zahra Moussavi, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After Aug. 2025', 'ipdSharing': 'YES', 'description': 'When the study is finished, de-identified data could be shared publicly by other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'BB Holistics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}