Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT04219566
Status:
COMPLETED
Last Update Posted:
2022-10-21
First Post:
2020-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vestibular Nerve Stimulation to Improve Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D020178', 'term': 'Sleep Disorders, Circadian Rhythm'}], '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'}, {'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D009784', 'term': 'Occupational Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blind (Subject, Nursing staff, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-05', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insomnia Severity Index (ISI) Scores', 'timeFrame': 'Day 0, Day 7, Day 14, Day 21, Day 28', 'description': 'ISI scores will be measured during the study and will be compared to baseline readings taken prior to intervention. Insomnia Severity Index scores range from 0 to 28. Scores greater than 15 indicate clinical insomnia.'}], 'secondaryOutcomes': [{'measure': 'EEG Assessment', 'timeFrame': 'Day 0, Day 28', 'description': 'EEG power in alpha band'}, {'measure': 'Depression Anxiety Stress Scales (DASS) Assessment', 'timeFrame': 'Day 0, Day 7, Day 14, Day 21, Day 28', 'description': 'DASS will be measured during the study and will be compared to baseline readings taken prior to intervention. DASS is scored from 0 to 42 with higher scores indicating more symptoms.'}, {'measure': 'WHO Quality of Life (WHOQOL) Assessment', 'timeFrame': 'Day 0, Day 7, Day 14, Day 21, Day 28', 'description': 'QOL will be measured during the study and will be compared to baseline readings taken prior to intervention. WHOQOL is scored from 0 to 100 with higher scores indicating a higher quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia', 'Sleep', 'Sleep Disorders, Circadian Rhythm']}, 'descriptionModule': {'briefSummary': 'A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings\n\nThe purpose of this investigation device study is to collect data that will be used to design appropriate pivotal studies that can be used for regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults\n* Both genders\n* Ages 18-24 years inclusive\n* Score above 14 in the insomnia severity index questionnaire\n* Willingness to participate in the study.\n\nExclusion Criteria:\n\n* Use sleep medication\n* Ear problems\n* Under any kind of treatment\n* Practicing sleep improving techniques\n* Any other significant health-related problems.'}, 'identificationModule': {'nctId': 'NCT04219566', 'briefTitle': 'Vestibular Nerve Stimulation to Improve Sleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurovalens Ltd.'}, 'officialTitle': 'Pilot Study to Demonstration of Safety and Efficacy of VeSTAL Sleep Device in Human Subjects: Randomized Study of VeSTAL Compared to Sham Control as a Means of Improving Sleep as Determined by ISI Scores', 'orgStudyIdInfo': {'id': 'IVS001S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active VeNS', 'description': 'The VeSTAL device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day in the period immediately prior to sleep onset.', 'interventionNames': ['Device: VeNS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham VeNS', 'description': 'The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day in the period immediately prior to sleep onset.', 'interventionNames': ['Device: Placebo device']}], 'interventions': [{'name': 'VeNS', 'type': 'DEVICE', 'description': 'Non-invasive electrical vestibular nerve stimulation', 'armGroupLabels': ['Active VeNS']}, {'name': 'Placebo device', 'type': 'DEVICE', 'description': 'Sham non-invasive electrical vestibular nerve stimulation', 'armGroupLabels': ['Sham VeNS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '456001', 'city': 'Ujjain', 'state': 'Madhya Pradesh', 'country': 'India', 'facility': 'RD Gardi Medical College', 'geoPoint': {'lat': 23.18239, 'lon': 75.77643}}], 'overallOfficials': [{'name': 'Sai Sailesh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RD Gardi Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurovalens Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'RD Gardi Medical College', 'class': 'UNKNOWN'}, {'name': 'Compliance Solutions Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}