Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 10:43 AM
Study NCT ID:
NCT04508595
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-08-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Algorithm', 'timeFrame': '1 year', 'description': 'Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients presenting to sleep medicine clinic for evaluation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages between 5 -75\n* General good health and ambulatory\n* Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likely concomitant abnormal LMS requiring either HST or PSG\n* Reports no significant problems sleeping in a new bed and bedroom away from home\n* (If applicable) Parent or guardian available to spend the night with the child during the sleep study\n\nExclusion Criteria:\n\n• Amputation that would preclude use of wrist actigraph or the RestEaze device'}, 'identificationModule': {'nctId': 'NCT04508595', 'briefTitle': 'The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanzen Medical Inc'}, 'officialTitle': 'The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance', 'orgStudyIdInfo': {'id': 'TM-RE1-OBS-0001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'RestEaze', 'type': 'DIAGNOSTIC_TEST', 'description': 'Wearable band to detect leg movements of sleep'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95035', 'city': 'Milpitas', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sanjay Agarwal, MD', 'role': 'CONTACT', 'email': 'drsanjay@yahoo.com', 'phone': '408-942-0300'}], 'facility': 'Comprehensive Sleep Center', 'geoPoint': {'lat': 37.42827, 'lon': -121.90662}}], 'centralContacts': [{'name': 'Justin Brooks, MD,PhD', 'role': 'CONTACT', 'email': 'jrybrooks@tanzenmed.com', 'phone': '7575811363'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanzen Medical Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}