Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
Study NCT ID:
NCT05948761
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2023-06-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Identical mode of administration and identical machinery used to deliver the intervention, only inside of machine is different (same ventilator, no active element in the placebo machine)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Hypoxic conditioning Placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Parkinson's disease Questionnaire-39 (PDQ-39)", 'timeFrame': '1 month', 'description': 'Lower indicates better score'}], 'primaryOutcomes': [{'measure': 'Number and nature of adverse events', 'timeFrame': '2 months'}, {'measure': 'Feasibility questionnaire, overall study success', 'timeFrame': '1 month', 'description': 'Higher indicates better score'}], 'secondaryOutcomes': [{'measure': 'MDS-UPDRS part II and III', 'timeFrame': '1 month', 'description': 'Lower indicates better score'}, {'measure': 'Purdue pegboard test (PPT)', 'timeFrame': '1 month', 'description': 'Higher indicates better score'}, {'measure': 'Timed up & Go Test (TUGT)', 'timeFrame': '1 month', 'description': 'Lower indicates better score'}, {'measure': 'Exercise tolerance (6-minute walk test, 6MWT)', 'timeFrame': '1 month', 'description': 'Higher indicates better score'}, {'measure': 'Accelerometry data for tremor amplitude', 'timeFrame': '1 month', 'description': 'Lower indicates better score'}, {'measure': 'Accelerometry data for pronation-supination', 'timeFrame': '1 month', 'description': 'Higher indicates better score'}, {'measure': 'Hematocrit', 'timeFrame': '1 month', 'description': 'Higher indicates better result'}, {'measure': 'Neurofilament light chain (NfL)', 'timeFrame': '1 month', 'description': 'Higher indicates better result'}, {'measure': 'BDNF', 'timeFrame': '1 month', 'description': 'Higher indicates better result'}, {'measure': 'Platelet-derived growth factor receptor beta (PDGFRβ)', 'timeFrame': '1 month', 'description': 'Higher indicates better result'}, {'measure': 'Clusterin', 'timeFrame': '1 month', 'description': 'Higher indicates better result'}, {'measure': 'GFAP', 'timeFrame': '1 month', 'description': 'Higher indicates better result'}, {'measure': 'UCH-L1', 'timeFrame': '1 month', 'description': 'Higher indicates better result'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '35836147', 'type': 'BACKGROUND', 'citation': "Janssen Daalen JM, Meinders MJ, Giardina F, Roes KCB, Stunnenberg BC, Mathur S, Ainslie PN, Thijssen DHJ, Bloem BR. Multiple N-of-1 trials to investigate hypoxia therapy in Parkinson's disease: study rationale and protocol. BMC Neurol. 2022 Jul 14;22(1):262. doi: 10.1186/s12883-022-02770-7."}, {'pmid': '38909201', 'type': 'DERIVED', 'citation': "Janssen Daalen JM, Meinders MJ, Mathur S, van Hees HWH, Ainslie PN, Thijssen DHJ, Bloem BR. Randomized controlled trial of intermittent hypoxia in Parkinson's disease: study rationale and protocol. BMC Neurol. 2024 Jun 22;24(1):212. doi: 10.1186/s12883-024-03702-3."}]}, 'descriptionModule': {'briefSummary': 'To explore the safety, feasibility and net symptomatic effects of multiple (3x/week, for 4 weeks) intermittent hypoxia treatment sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.', 'detailedDescription': "Intermittent hypoxia therapy is a non-pharmacological intervention used by athletes and individuals with cardiovascular disease, amongst others. The safety and feasibility of (intermittent) hypoxia therapy and its short-term effects on Parkinson's disease (PD) symptoms were assessed in a previous exploratory phase I trial. However, the net effects of multiple hypoxia treatment sessions on PD symptoms are unknown. The results of the previous phase I trial informed the study design of the newly proposed phase 1b-2a safety and efficacy trial.\n\n45 minutes of normobaric intermittent hypoxia (FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia) will be delivered via a hypoxicator (a device that titrates decreased fractional oxygen from room air) through an oxygen mask in the hospital and subsequently at participants' homes. Interventions will be conducted 3 times a week, for 4 weeks in total."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Informed consent\n* Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist.\n* Hoehn and Yahr staging 1 to and including 3 (indicating mild to moderate PD).\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Individuals with diseases leading to restrictive and obstructive pulmonary diseases, sleep apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively\n* Individuals with coronary artery disease NYHA classes III and IV\n* Arterial blood gas abnormalities at screening procedure\n* Individuals with shortness of breath or other airway or breathing-related inconvenience related to lack of dopaminergic medication\n* Inability for in-clinic measurements in OFF phase\n* Individuals with active deep brain stimulation"}, 'identificationModule': {'nctId': 'NCT05948761', 'acronym': 'TALISMAN-2', 'briefTitle': "Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': "A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease", 'orgStudyIdInfo': {'id': '114210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Hypoxic generator without active elements, pulsewise ventilation assured to ascertain blinding', 'interventionNames': ['Other: Normoxia through hypoxic generator without active elements']}, {'type': 'EXPERIMENTAL', 'label': 'Active intervention', 'description': 'FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia (intermittent hypoxia)', 'interventionNames': ['Other: Hypoxia through modified hypoxic generator']}], 'interventions': [{'name': 'Hypoxia through modified hypoxic generator', 'type': 'OTHER', 'description': 'Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants.', 'armGroupLabels': ['Active intervention']}, {'name': 'Normoxia through hypoxic generator without active elements', 'type': 'OTHER', 'description': 'Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants, without active elements.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525EX', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Dpt. of Physiology, Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '1.5 years', 'ipdSharing': 'YES', 'description': "Anonymized data will be shared with The Michael J. Fox Foundation for Parkinson's Research (the study funder). This data may be kept for storage at a central repository either hosted by The Michael J. Fox Foundation, its collaborators, or consultants and will be kept indefinitely. Anonymized data will be made publicly available for the intended use of research in Parkinson's disease as well as other biomedical research studies that may not be related to Parkinson's disease."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}