Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

NCT05948761 | Completed Phase 1 DMC

• 1 other identifier: 114210
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Number and nature of adverse events

  2 months

• Feasibility questionnaire, overall study success

  Higher indicates better score

  1 month

Secondary Outcomes (13)

• MDS-UPDRS part II and III

  1 month

• Purdue pegboard test (PPT)

  1 month

• Timed up & Go Test (TUGT)

  1 month

• Exercise tolerance (6-minute walk test, 6MWT)

  1 month

• Accelerometry data for tremor amplitude

  1 month

Other Outcomes (1)

• Parkinson's disease Questionnaire-39 (PDQ-39)

  1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Hypoxic generator without active elements, pulsewise ventilation assured to ascertain blinding

Other: Normoxia through hypoxic generator without active elements

Active intervention

EXPERIMENTAL

FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia (intermittent hypoxia)

Other: Hypoxia through modified hypoxic generator

Interventions

Hypoxia through modified hypoxic generator OTHER

Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants.

Active intervention

Normoxia through hypoxic generator without active elements OTHER

Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants, without active elements.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist.
• Hoehn and Yahr staging 1 to and including 3 (indicating mild to moderate PD).

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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
• Individuals with coronary artery disease NYHA classes III and IV
• Arterial blood gas abnormalities at screening procedure
• Individuals with shortness of breath or other airway or breathing-related inconvenience related to lack of dopaminergic medication
• Inability for in-clinic measurements in OFF phase
• Individuals with active deep brain stimulation

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

Dpt. of Physiology, Radboud University Medical Center

Nijmegen, 6525EX, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Related Publications (2)

• 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: 35836147 BACKGROUND

• 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.

  PMID: 38909201 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hypoxic conditioning Placebo

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 17, 2023
• Study Start: July 4, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: August 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 1.5 years

Locations

NL (2)