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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54087

Enrollment

Registered

2022-01-26

Start date

2022-02-22

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Parkinson's disease

Interventions

Normobaric hypoxia will be delivered provided via an oxygen mask: one of the following in OFF-condition: continuous hypoxia comparable to 2000m altitude (16.3% O2) for 45 minutes, continuous hypoxia

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary - Self-reported overall symptom impression and one important or altitude-responsive symptom chosen by participant on Likert scale 1-10 (allowing half points), as well as urge to take dopaminergic medication on usual moments of intake, on 10-point scale ranging from substantially less to substantially more (allowing half points). - Bradykinesia quantified using a Modified Perdue pegboard test) - Mobility (Timed Up & Go Test, steps and time) - Balance (MiniBES test, totaal- en subscore) - Movement Disorder Society-Unified Parkinsons Disease Rating Scale (MDS-UPDRS) part III (sum score and individual elements) - Finger tapping test (amount of taps and errors) - Accelerometry registration of hand tremor (with Movisens Move 4 accelerometer) - Non-motor symptoms (stress, mood, anxiety, pain, fatigue) on Likert scale 1-10 (allowing half points). - Heartrate variability (using Polar smartwatch) Lab outcomes: - Serum platelet-derived growth factor receptor β (PDGFRβ) from baseline ABG and last ABG during intervention (fifth ABG including baseline) - Serum cortisol before and after baseline clinical assessment, and three ABGs (between directly post-intervention and +-40 minutes post-intervention). - Serum erythropoietin before baseline and last blood gas (+- 40 minutes post-intervention). - Venous blood gas at baseline and blood draw at the end of the intervention Other characteristics and effect modifiers: - Baseline characteristics (age, gender, PD severity (Hoehn and Yahr), disease duration, quality of life (Parkinsons Disease Questionnaire 39-PDQ39), pulmonary function testing, diffusion capacity (DLCO), p0.1, MIP, other medication (e.g. beta-antagonists) - Potential effect modifiers (measured before every intervention): levodopa equivalent daily dose, sleep (item 9 of PSQI), physical activity (IPAQ-SF)	—

Measure

Time frame

Secondary - Self-reported overall symptom impression and one important or altitude-responsive symptom chosen by participant on Likert scale 1-10 (allowing half points), as well as urge to take dopaminergic medication on usual moments of intake, on 10-point scale ranging from *substantially less* to *substantially more* (allowing half points). - Bradykinesia quantified using a Modified Perdue pegboard test) - Mobility (Timed Up & Go Test, steps and time) - Balance (MiniBES test, totaal- en subscore) - Movement Disorder Society-Unified Parkinson*s Disease Rating Scale (MDS-UPDRS) part III (sum score and individual elements) - Finger tapping test (amount of taps and errors) - Accelerometry registration of hand tremor (with Movisens Move 4 accelerometer) - Non-motor symptoms (stress, mood, anxiety, pain, fatigue) on Likert scale 1-10 (allowing half points). - Heartrate variability (using Polar smartwatch) Lab outcomes: - Serum platelet-derived growth factor receptor β (PDGFRβ) from baseline ABG and last ABG during intervention (fifth ABG including baseline) - Serum cortisol before and after baseline clinical assessment, and three ABGs (between directly post-intervention and +-40 minutes post-intervention). - Serum erythropoietin before baseline and last blood gas (+- 40 minutes post-intervention). - Venous blood gas at baseline and blood draw at the end of the intervention Other characteristics and effect modifiers: - Baseline characteristics (age, gender, PD severity (Hoehn and Yahr), disease duration, quality of life (Parkinson*s Disease Questionnaire 39-PDQ39), pulmonary function testing, diffusion capacity (DLCO), p0.1, MIP, other medication (e.g. beta-antagonists) - Potential effect modifiers (measured before every intervention): levodopa equivalent daily dose, sleep (item 9 of PSQI), physical activity (IPAQ-SF)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026