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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-04

Study Completion Date

2024-08-30

Brief Summary

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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.

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Detailed Description

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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.

45 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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Hypoxic conditioning Placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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)

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Normoxia through hypoxic generator without active elements

Intervention Type OTHER

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

Active intervention

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

Group Type EXPERIMENTAL

Hypoxia through modified hypoxic generator

Intervention Type OTHER

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

Interventions

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Hypoxia through modified hypoxic generator

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

Intervention Type OTHER

Normoxia through hypoxic generator without active elements

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

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, 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No