Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-03-22 @ 9:28 AM
Study NCT ID:
NCT02874261
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2016-08-19', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep patterns using an activity monitor on the wrist', 'timeFrame': '6 weeks', 'description': 'The investigators will record sleep patterns a week before WBPA through out the 4 weeks of WBPA and then one week post WBPA using an activity monitor on the wrist'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '6 weeks', 'description': 'This is a quantitative tool to measure sleep as well as an activity monitor twenty -four hours for seven days at a time'}, {'measure': 'Physical Activity (steps per day using an activity monitor on the wrist)', 'timeFrame': '6 weeks', 'description': 'The investigators will record steps per day a week before WBPA through out the 4 weeks of WBPA and then one week post WBPA using an activity monitor on the wrist'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Disorders', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional.\n\nThe science behind the therapeutic effects of WBPA still remains largely unknown.\n\nThe investigators are observing how WBPA may impact on sleep and activity in individuals with Parkinson\'s disease.', 'detailedDescription': 'Sleep disturbances are common in individuals with Parkinson\'s Disease. Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." WBPA has been shown in previous studies to increase nitric oxide. Increased levels of nitric oxide have been shown to improve sleep patterns in other populations. The current pilot study will investigate how WBPA will impact upon sleep disturbances in subjects with Parkinson\'s disease who suffer from abnormal sleep patterns. The investigators will record sleep patterns and activity levels using a Jawbone U3® activity monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy individuals between the ages of 50-80\n* Individuals with Parkinsons disease between the ages of 50-80\n* Individuals with a smart phone\n\nExclusion Criteria:\n\n* Any condition that prevents you from lying flat on your back, any other neurological condition than Parkinson's disease."}, 'identificationModule': {'nctId': 'NCT02874261', 'briefTitle': "Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'New York Institute of Technology'}, 'officialTitle': "Effects of Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease", 'orgStudyIdInfo': {'id': 'BHS-1124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole Body Periodic Acceleration', 'description': 'Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation is 120 cycles/minute; cpm) as well as a distance traveled 16 mm.', 'interventionNames': ['Device: Whole Body Periodic Acceleration']}], 'interventions': [{'name': 'Whole Body Periodic Acceleration', 'type': 'DEVICE', 'otherNames': ['WBPA'], 'description': 'oscillating bed that the subject will lie on 3 days a week for 45 minutes at 140 cycles per minute.', 'armGroupLabels': ['Whole Body Periodic Acceleration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11568568', 'city': 'Old Westbury', 'state': 'New York', 'country': 'United States', 'facility': 'NYIT', 'geoPoint': {'lat': 40.78871, 'lon': -73.59957}}], 'overallOfficials': [{'name': 'Veronica Southard, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYIT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Institute of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}