An N-of-1 double-blind randomized phase 1 trial of the safety and feasibility of (intermittent) hypoxia therapy in Parkinson*s disease

Completed

• Conditions: Parkinson's disease; Parkinson's; 10028037

• Registration Number: NL-OMON54087
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-11-17
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Able to provide informed consent
- Age >18 years
- Clinical diagnosis of Parkinson*s disease by a movement disorder specialized
neurologist with Hoehn and Yahr staging 1.5 to 3.
- (for age-matched controls: all of the above, except for PD)

Exclusion Criteria

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, pulmonary diffusion deficits, apnea and cardiac output deficits, such
as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), sleep
apnea or excessive alcoholic intake, and congestive heart failure respectively.
- Arterial blood gas abnormalities at screening
- Individuals with shortness of breath or other airway or breathing-related
inconvenience related to lack of dopaminergic medication will be excluded.
- Inability to comply to intervention in off-medication condition (for example
due to extreme discomfort, distress or severe head tremor due to being OFF,
i.e. without dopaminergic medication).
- Individuals with unstable dopaminergic medication dose (changes in the last
month)
- Individuals likely to start dopaminergic treatment in the next month, also
judged by their treating neurologist
- Individuals with active deep brain stimulation
- Individuals unable to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>As this is an exploratory study, primary outcomes are multidimensional and<br /><br>assess safety as well as feasibility of this study:<br /><br>- Nature and total number of adverse events (including vital parameters<br /><br>abnormalities)<br /><br>- Feasibility questionnaire (including feasibility questionnaire sum score)<br /><br>- Sensitivity (change) of secondary outcome measures pre- and postintervention</p><br>