Parkinson DiseasePhase 1/2TALISMAN-2NCT05948761
Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
A Phase 1/2 study testing Hypoxia through modified hypoxic generator and Normoxia through hypoxic generator without active elements in people with Parkinson Disease, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Hypoxia through modified hypoxic generator and Normoxia through hypoxic generator without active elements
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- 4 Jul 2023to 30 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Netherlands2 sites
Dpt. of Physiology, Radboud University Medical Center
Nijmegen, 6525EX
Radboud University Medical Center
Nijmegen
About this study
Official title: A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
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.
Read the detailed 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.
- Conditions
- Parkinson Disease
- Being tested
- Hypoxia through modified hypoxic generator, Normoxia through hypoxic generator without active elements
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia through modified hypoxic generatorOther
Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants.
Normoxia through hypoxic generator without active elementsOther
Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants, without active elements.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Hypoxic generator without active elements, pulsewise ventilation assured to ascertain blinding Receives: Other: Normoxia through hypoxic generator without active elements |
| Active intervention | Experimental | FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia (intermittent hypoxia) Receives: Other: Hypoxia through modified hypoxic generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and nature of adverse events
Measured: 2 months
Feasibility questionnaire, overall study success
Higher indicates better score
Measured: 1 month
Secondary outcomes (13)
MDS-UPDRS part II and III
Lower indicates better score
Measured: 1 month
Purdue pegboard test (PPT)
Higher indicates better score
Measured: 1 month
Timed up & Go Test (TUGT)
Lower indicates better score
Measured: 1 month
Exercise tolerance (6-minute walk test, 6MWT)
Higher indicates better score
Measured: 1 month
Accelerometry data for tremor amplitude
Lower indicates better score
Measured: 1 month
Accelerometry data for pronation-supination
Higher indicates better score
Measured: 1 month
Hematocrit
Higher indicates better result
Measured: 1 month
Neurofilament light chain (NfL)
Higher indicates better result
Measured: 1 month
BDNF
Higher indicates better result
Measured: 1 month
Platelet-derived growth factor receptor beta (PDGFRβ)
Higher indicates better result
Measured: 1 month
Clusterin
Higher indicates better result
Measured: 1 month
GFAP
Higher indicates better result
Measured: 1 month
UCH-L1
Higher indicates better result
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start4 Jul 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hypoxic conditioning Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948761
- Sponsor's protocol ID
- 114210
- Acronym
- TALISMAN-2
- Status last verified
- Dec 2024
- First submitted
- 20 Jun 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared with The Michael J. Fox Foundation for Parkinson's Research (the study funder). This data may be kept for storage at a central repository either hosted by The Michael J. Fox Foundation, its collaborators, or consultants and will be kept indefinitely. Anonymized data will be made publicly available for the intended use of research in Parkinson's disease as well as other biomedical research studies that may not be related to Parkinson's disease.
Publications
Janssen Daalen JM, Meinders MJ, Giardina F, Roes KCB, Stunnenberg BC, Mathur S, Ainslie PN, Thijssen DHJ, Bloem BR. Multiple N-of-1 trials to investigate hypoxia therapy in Parkinson's disease: study rationale and protocol. BMC Neurol. 2022 Jul 14;22(1):262. doi: 10.1186/s12883-022-02770-7.
PubMed 35836147Janssen Daalen JM, Meinders MJ, Mathur S, van Hees HWH, Ainslie PN, Thijssen DHJ, Bloem BR. Randomized controlled trial of intermittent hypoxia in Parkinson's disease: study rationale and protocol. BMC Neurol. 2024 Jun 22;24(1):212. doi: 10.1186/s12883-024-03702-3.
PubMed 38909201
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05948761
- Acronym / sponsor ID
- TALISMAN-2 / 114210
- Conditions
- Parkinson Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Hypoxic conditioning Placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Normoxia through hypoxic generator without active elementsHypoxic generator without active elements, pulsewise ventilation assured to ascertain blinding |
| Active intervention | Experimental | Other: Hypoxia through modified hypoxic generatorFiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia (intermittent hypoxia) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxia through modified hypoxic generatorCommercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants. | Other | Active intervention |
| Normoxia through hypoxic generator without active elementsCommercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants, without active elements. | Other | Placebo |
Primary outcome
Number and nature of adverse events
Time frame: 2 months
Feasibility questionnaire, overall study success
Time frame: 1 month
Higher indicates better score
13 secondary outcomes
MDS-UPDRS part II and III
Time frame: 1 month
Purdue pegboard test (PPT)
Time frame: 1 month
Timed up & Go Test (TUGT)
Time frame: 1 month
Exercise tolerance (6-minute walk test, 6MWT)
Time frame: 1 month
Accelerometry data for tremor amplitude
Time frame: 1 month
Accelerometry data for pronation-supination
Time frame: 1 month
Hematocrit
Time frame: 1 month
Neurofilament light chain (NfL)
Time frame: 1 month
BDNF
Time frame: 1 month
Platelet-derived growth factor receptor beta (PDGFRβ)
Time frame: 1 month
Clusterin
Time frame: 1 month
GFAP
Time frame: 1 month
UCH-L1
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 35836147Janssen Daalen JM, Meinders MJ, Giardina F, Roes KCB, Stunnenberg BC, Mathur S, Ainslie PN, Thijssen DHJ, Bloem BR. Multiple N-of-1 trials to investigate hypoxia therapy in Parkinson's disease: study rationale and protocol. BMC Neurol. 2022 Jul 14;22(1):262. doi: 10.1186/s12883-022-02770-7.
- Derived from this study: PubMed 38909201Janssen Daalen JM, Meinders MJ, Mathur S, van Hees HWH, Ainslie PN, Thijssen DHJ, Bloem BR. Randomized controlled trial of intermittent hypoxia in Parkinson's disease: study rationale and protocol. BMC Neurol. 2024 Jun 22;24(1):212. doi: 10.1186/s12883-024-03702-3.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared with The Michael J. Fox Foundation for Parkinson's Research (the study funder). This data may be kept for storage at a central repository either hosted by The Michael J. Fox Foundation, its collaborators, or consultants and will be kept indefinitely. Anonymized data will be made publicly available for the intended use of research in Parkinson's disease as well as other biomedical research studies that may not be related to Parkinson's disease.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hypoxia through modified hypoxic generator and Normoxia through hypoxic generator without active elements in people with Parkinson Disease, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and nature of adverse events (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948761, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.