A randomized phase 1b/2a trial of the effectiveness of intermittent hypoxia interventions in Parkinson*s disease

A randomized phase 1b/2a trial of the effectiveness of intermittent hypoxia interventions in Parkinson*s disease - TALISMAN-2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53977

Enrollment

Registered

2023-06-21

Start date

2023-07-20

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

45 minutes of normobaric intermittent hypoxia (FiO2 0.163 for 5 minutes interspersed with 5 minutes normoxia) will be delivered via a hypoxicator (a device that titrates decreased fractional oxygen

Eligibility

Age

18 Years to 99 Years

Inclusion 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). - Availability of an observant (partner, family member, friend, other relative) during at-home hypoxic interventions.

Exclusion criteria

Exclusion criteria: - Individuals with diseases leading to restrictive and obstructive pulmonary diseases, apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively, and individuals with coronary artery disease NYHA classes III and IV - Arterial blood gas abnormalities at screening procedure (as per normal limits in chapter 8.1.1) - 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

Design outcomes

Primary

Measure	Time frame
- Number and nature of adverse events - Movement Disorder Society-Unified Parkinson*s Disease Rating Scale (MDS-UPDRS) part II and part III score (Activities of Daily Living and Motor score). - Feasibility questionnaire	—

Secondary

Measure	Time frame
- Purdue pegboard test (PPT) - Timed Up & Go Test (TUGT), time and steps - MDS Non-Motor Scale (NMSS) - Parkinson*s disease questionnaire-39 (PDQ-39) - Accelerometry data on tremor and pronation-supination as part of the MDS-UPDRS III (using the Movisens® Move 4 activity sensor) - Hypoxic ventilatory response (ventilation, breathing frequency, tidal volume) - Hematocrit, neurofilament light chain (NfL), clusterin, GFAP, UCH-L1, BDNF, platelet-derived growth factor receptor beta (PDGFRβ).	—

Measure

Time frame

- Purdue pegboard test (PPT) - Timed Up & Go Test (TUGT), time and steps - MDS Non-Motor Scale (NMSS) - Parkinson*s disease questionnaire-39 (PDQ-39) - Accelerometry data on tremor and pronation-supination as part of the MDS-UPDRS III (using the Movisens® Move 4 activity sensor) - Hypoxic ventilatory response (ventilation, breathing frequency, tidal volume) - Hematocrit, neurofilament light chain (NfL), clusterin, GFAP, UCH-L1, BDNF, platelet-derived growth factor receptor beta (PDGFRβ).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026