Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-13 @ 1:03 PM
Study NCT ID:
NCT03771794
Status:
UNKNOWN
Last Update Posted:
2018-12-11
First Post:
2018-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Variability Augmentation With RR2 Neuromodulation Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Active Comparator: ReguRate RR2 active. Device: ReguRate neurostimulation system\n\nSham Comparator: ReguRate RR2 placebo. Device: Sham ReguRate electrical stimulation - mock sham stimulation mode'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-10', 'studyFirstSubmitDate': '2018-12-09', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of patients with 5% or more decrease in blood pressure', 'timeFrame': '1 week'}, {'measure': 'Percentage of patients with change in additional HRV parameters (rMSSD, LF,HF,L/HF)', 'timeFrame': '1 week'}], 'primaryOutcomes': [{'measure': 'Percentage of patients with 15% or HRV change immediately after neurostimulation session', 'timeFrame': '1 week', 'description': 'HRV augmentation'}], 'secondaryOutcomes': [{'measure': 'Decrease in heart rate', 'timeFrame': '1 week', 'description': 'Percentage of patients with 5% or more decrease in heart rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HRV', 'Peripheral neuromodulation', 'Autonomic balance'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Brief Summary: A randomized double-blinded, sham-controlled, crossover study\n\nCondition or Disease: impaired autonomic balance measured by heart rate variability', 'detailedDescription': 'A randomized double-blinded, sham-controlled, crossover study\n\nCondition or Disease: impaired autonomic balance measured by heart rate variability\n\nIntervention/treatment:\n\nDevice: ReguRate RR2 neurostimulation system Device: Sham ReguRate RR2 neurostimulation system\n\nStudy Design:\n\nStudy Type: Interventional (clinical trial) Planned enrollment: 60 participants Allocation: Randomized Intervention Model; Cross Over Masking: Double (participant, Investigator) Primary Purpose: Treatment Official Title: Non-Invasive peripheral neuromodulation to augment HRV in healthy adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nInclusion criteria :\n\n1. Healthy male and female volunteers ages 25-60\n2. 2 minute HRV measurement with SDNN\\<35 ms (below 35 ms)\n3. Participants able and willing to comply with the study protocol\n4. Participants able and willing to sign a written informed consent\n\nExclusion Criteria:\n\n\\-\n\nExclusion criteria :\n\n1. Participant with a known cardiovascular disease\n2. Participants with COPD\n3. Participants with any known history of epilepsy\n4. Participants with detected arrhythmia on test day\n5. Participants with implanted electrical and/or neurostimulation device (such as cardiac pace maker/defibrillator/VNS stimulator/SNS stimulator/occipital nerve stimulator/deep brain stimulator etc.)\n6. Heavy smokers (more than 1 package of cigarets a day)\n7. Participants with a plan to change medications\n8. History of vasovagal syncope\n9. Pregnancy or bleeding\n10. Participants enrolled in another clinical trial'}, 'identificationModule': {'nctId': 'NCT03771794', 'briefTitle': 'Heart Rate Variability Augmentation With RR2 Neuromodulation Device', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults', 'orgStudyIdInfo': {'id': '0024-18-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: ReguRate RR2 active', 'description': 'Device: ReguRate neurostimulation device', 'interventionNames': ['Device: ReguRate neurostimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Comparator: ReguRate RR2 sham.', 'description': 'Device: Sham ReguRate neurostimulation - mock sham stimulation mode', 'interventionNames': ['Device: ReguRate neurostimulation']}], 'interventions': [{'name': 'ReguRate neurostimulation', 'type': 'DEVICE', 'otherNames': ['Sham ReguRate neurostimulation - mock sham stimulation mode'], 'description': 'Device: ReguRate neurostimulation Device:\n\nSham : ReguRate neurostimulation - mock sham stimulation mode', 'armGroupLabels': ['Active Comparator: ReguRate RR2 active', 'Sham Comparator: ReguRate RR2 sham.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sharon Tsuk, PhD', 'role': 'CONTACT'}, {'name': 'Raffael Carasso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sharon Tsuk, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Wingate Institute', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'city': 'Netanya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sharon', 'role': 'CONTACT'}], 'facility': 'Wingate Institute', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Sharon Tsuk, PHD', 'role': 'CONTACT', 'email': 'sharontsuk1@gmail.com', 'phone': '972-9-8639368'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of Helsinki Ethics Committee', 'investigatorFullName': 'Prof. Ahud Sternberg', 'investigatorAffiliation': 'Hillel Yaffe Medical Center'}}}}