Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease (TALISMAN-2)

Radboud University Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Parkinson Disease

Treatments: Other: Hypoxia through modified hypoxic generator; Other: Normoxia through hypoxic generator without active elements

Study type: Interventional

Funder types: Other

Identifiers

NCT05948761

114210

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Normoxia through hypoxic generator without active elements

Active intervention

Experimental group

Description:

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

Treatment:

Other: Hypoxia through modified hypoxic generator