Parkinson DiseasePhase 2NCT05700825
Rehabilitation of Airway Protection in Parkinson's Disease
A Phase 2 study testing Expiratory Muscle Strength Training + Cough Skill Training in people with Parkinson Disease and Dysphagia, run by Teachers College, Columbia University at 2 sites in United States.
Trial summary
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Parkinson Disease, Dysphagia
- What is being tested?
- Expiratory Muscle Strength Training + Cough Skill Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Aug 2022to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using strict UK brain bank criteria
- airway protective deficits as defined as a minimum of penetration of thin liquids (penetration-aspiration score>3) as determined by instrumental swallowing assessment and/or dystussia as determined by voluntary cough assessment (PEFR ≤4.1 L/s)
- not actively receiving exercise-based swallowing therapy
- between the ages of 50 and 90.
Who cannot join
- Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.)
- history of head and neck cancer
- history of breathing disorders or diseases (e.g., COPD)
- history of smoking in the last five years
- uncontrolled hypertension
- difficulty complying due to neuropsychological dysfunction (i.e., severe depression with >28 on the Beck Depression Index (BDI-II), dementia with <19 on the Montreal Cognitive Assessment (MoCA))
- allergy to capsaicin or barium
- further than 1.5 hours (door to door) distance from either Teachers College, Columbia University or Purdue University.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Teachers College, Columbia University
New York, New York, 10027
Michelle Troche, PhD, 212-678-3072, mst2139@tc.columbia.edu
- Active, not recruiting
Purdue University
West Lafayette, Indiana, 47907
About this study
Official title: Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-person and Telehealth Service Delivery Models
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.
Read the detailed description
Progressive disorders of airway protection, such as swallowing disorders (dysphagia) and cough disorders (dystussia), are highly prevalent in PD and have significant negative implications for health and quality of life. In fact, aspiration pneumonia, commonly associated with dysphagia/dystussia, is a leading cause of death in PD. Despite this, there is currently no established standard of care for the treatment of airway protective disorders in this population. Even more critically, approximately 40% of individuals with PD in the United States do not access rehabilitation services or receive specialized care for these potentially life-threatening airway protective deficits. Expiratory Muscle Strength Training (EMST) and Cough Skill Training (CST) have been found to improve airway protective disorders in PD and be feasible via telehealth. However, a significant clinical-research gap remains in that it has not been demonstrated that clinical outcomes are comparable (non-inferior) when these treatments are delivered via telehealth versus in-person. This gap limits access to these important services with detrimental effects to health and quality of life. The long-term goal of this line of research is to improve the health outcomes of individuals with PD, specifically as they relate to airway protective dysfunction. The objective of this application is to pair EMST + CST - and compare clinical and patient-centered outcomes when conducted in-person versus via telehealth in the short- and the long-term. Also, the investigators will assess the role of specific patient burden factors and resultant treatment adherence on clinical outcomes. Therefore, the aims of this study are to: 1) Compare clinical and patient-centered outcomes following four weeks of intensive in-person vs. telehealth EMST+CST treatment in persons with PD, 2) Compare clinical and patient-centered outcomes from a long-term EMST+CST maintenance program offered in-person vs. via telehealth in persons with PD, and 3) Identify the role of specific patient burden factors (i.e., geographic location, cognitive function, disease severity, and caregiver burden) on treatment adherence in the short- and long-term and the influence of treatment adherence on clinical outcomes. The investigators will achieve these aims by conducting a two-arm, two site, randomized clinical trial in 120 people with PD comparing in-person vs. telehealth EMST+CST treatment after a four-week intensive period (aim1) and after a one year maintenance treatment period (with assessments at six and 12 months - aim 2). The investigators anticipate our findings will result in immediately translatable clinical deliverables that will have broad impact for reduced burden and improved accessibility of treatment. Further, these findings will inform our future studies investigating these treatments and service delivery models on long-term outcomes (i.e., aspiration pneumonia, hospitalization, death), accessibility, and healthcare costs.
- Conditions
- Parkinson Disease, Dysphagia
- Being tested
- Expiratory Muscle Strength Training + Cough Skill Training
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Muscle Strength Training + Cough Skill TrainingBehavioural
Expiratory Muscle Strength Training (EMST). EMST is a widely used and efficacious treatment approach that uses a calibrated device with a one-way, spring-loaded pressure relief valve to mechanically overload the expiratory and submental muscles.
Cough Skill Training (CST) involves a digital peak flow meter device which measures PEFR (peak expiratory flow rate) in liters/second and allows patients to receive immediate biofeedback.
| Study group | Role | What they receive |
|---|---|---|
| In-person | Active comparator | Not described Receives: Behavioral: Expiratory Muscle Strength Training + Cough Skill Training |
| Telehealth | Experimental | Not described Receives: Behavioral: Expiratory Muscle Strength Training + Cough Skill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1
Measured: Pretraining to posttraining (after four weeks of intensive training)
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 2
Measured: post-training to post one-year maintenance
Change in Penetration-Aspiration Scale (PAS) - phase 1
PAS, max value: 8 (most impaired), min value 1 (least impaired).
Measured: Pretraining to posttraining (after four weeks of intensive training)
Change in Penetration-Aspiration Scale (PAS) - phase 2
PAS, max value: 8 (most impaired), min value 1 (least impaired).
Measured: post-training to post one-year maintenance
Secondary outcomes (8)
Change in Maximum Expiratory Pressure - phase 1
Measured: Pretraining to posttraining (after four weeks of intensive training)
Change in Maximum Expiratory Pressure - phase 2
Measured: post-training to post one-year maintenance
Change in Cough expired volume - phase 1
Measured: Pretraining to posttraining (after four weeks of intensive training)
Change in Cough expired volume - phase 2
Measured: post-training to post one-year maintenance
Treatment Adherence - phase 1
percent of prescribed training coughs and breaths completed
Measured: posttraining (after four weeks of intensive training)
Change in Treatment Adherence- phase 2
percent of prescribed training coughs and breaths completed
Measured: post-training to post one-year maintenance
Change in SWAL-QOL- phase 1
self-report questionnaire of swallowing quality of life, 44 min score, 220 max score - higher score is better QOL
Measured: Pretraining to posttraining (after four weeks of intensive training)
Change in SWAL-QOL - phase 2
self-report questionnaire of swallowing quality of life, 44 min score, 220 max score - higher score is better QOL
Measured: post-training to post one-year maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start11 Aug 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Purdue University
- Responsible party
- Principal investigator, Michelle Troche, Teachers College, Columbia University
- Investigators
- Michelle Troche, PhD, Principal investigator, Teachers College, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700825
- Sponsor's protocol ID
- NS126319
- Other IDs
- 1R01NS126319
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-person and Telehealth Service Delivery Models
- ClinicalTrials.gov ID
- NCT05700825
- Acronym / sponsor ID
- NS126319
- Conditions
- Parkinson Disease, Dysphagia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Purdue University
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 26 Jan 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.
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.
Detailed description
Progressive disorders of airway protection, such as swallowing disorders (dysphagia) and cough disorders (dystussia), are highly prevalent in PD and have significant negative implications for health and quality of life. In fact, aspiration pneumonia, commonly associated with dysphagia/dystussia, is a leading cause of death in PD. Despite this, there is currently no established standard of care for the treatment of airway protective disorders in this population. Even more critically, approximately 40% of individuals with PD in the United States do not access rehabilitation services or receive specialized care for these potentially life-threatening airway protective deficits. Expiratory Muscle Strength Training (EMST) and Cough Skill Training (CST) have been found to improve airway protective disorders in PD and be feasible via telehealth. However, a significant clinical-research gap remains in that it has not been demonstrated that clinical outcomes are comparable (non-inferior) when these treatments are delivered via telehealth versus in-person. This gap limits access to these important services with detrimental effects to health and quality of life. The long-term goal of this line of research is to improve the health outcomes of individuals with PD, specifically as they relate to airway protective dysfunction. The objective of this application is to pair EMST + CST - and compare clinical and patient-centered outcomes when conducted in-person versus via telehealth in the short- and the long-term. Also, the investigators will assess the role of specific patient burden factors and resultant treatment adherence on clinical outcomes. Therefore, the aims of this study are to: 1) Compare clinical and patient-centered outcomes following four weeks of intensive in-person vs. telehealth EMST+CST treatment in persons with PD, 2) Compare clinical and patient-centered outcomes from a long-term EMST+CST maintenance program offered in-person vs. via telehealth in persons with PD, and 3) Identify the role of specific patient burden factors (i.e., geographic location, cognitive function, disease severity, and caregiver burden) on treatment adherence in the short- and long-term and the influence of treatment adherence on clinical outcomes. The investigators will achieve these aims by conducting a two-arm, two site, randomized clinical trial in 120 people with PD comparing in-person vs. telehealth EMST+CST treatment after a four-week intensive period (aim1) and after a one year maintenance treatment period (with assessments at six and 12 months - aim 2). The investigators anticipate our findings will result in immediately translatable clinical deliverables that will have broad impact for reduced burden and improved accessibility of treatment. Further, these findings will inform our future studies investigating these treatments and service delivery models on long-term outcomes (i.e., aspiration pneumonia, hospitalization, death), accessibility, and healthcare costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person | Active comparator | Behavioral: Expiratory Muscle Strength Training + Cough Skill Training |
| Telehealth | Experimental | Behavioral: Expiratory Muscle Strength Training + Cough Skill Training |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using strict UK brain bank criteria
- airway protective deficits as defined as a minimum of penetration of thin liquids (penetration-aspiration score>3) as determined by instrumental swallowing assessment and/or dystussia as determined by voluntary cough assessment (PEFR ≤4.1 L/s)
- not actively receiving exercise-based swallowing therapy
- between the ages of 50 and 90.
Key exclusion criteria (8 listed)
- Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.)
- history of head and neck cancer
- history of breathing disorders or diseases (e.g., COPD)
- history of smoking in the last five years
- uncontrolled hypertension
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 |
|---|---|---|
| Expiratory Muscle Strength Training + Cough Skill TrainingExpiratory Muscle Strength Training (EMST). EMST is a widely used and efficacious treatment approach that uses a calibrated device with a one-way, spring-loaded pressure relief valve to mechanically overload the expiratory and submental muscles. Cough Skill Training (CST) involves a digital peak flow meter device which measures PEFR (peak expiratory flow rate) in liters/second and allows patients to receive immediate biofeedback. | Behavioural | In-person, Telehealth |
Primary outcome
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1
Time frame: Pretraining to posttraining (after four weeks of intensive training)
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 2
Time frame: post-training to post one-year maintenance
Change in Penetration-Aspiration Scale (PAS) - phase 1
Time frame: Pretraining to posttraining (after four weeks of intensive training)
PAS, max value: 8 (most impaired), min value 1 (least impaired).
Change in Penetration-Aspiration Scale (PAS) - phase 2
Time frame: post-training to post one-year maintenance
PAS, max value: 8 (most impaired), min value 1 (least impaired).
8 secondary outcomes
Change in Maximum Expiratory Pressure - phase 1
Time frame: Pretraining to posttraining (after four weeks of intensive training)
Change in Maximum Expiratory Pressure - phase 2
Time frame: post-training to post one-year maintenance
Change in Cough expired volume - phase 1
Time frame: Pretraining to posttraining (after four weeks of intensive training)
Change in Cough expired volume - phase 2
Time frame: post-training to post one-year maintenance
Treatment Adherence - phase 1
Time frame: posttraining (after four weeks of intensive training)
Change in Treatment Adherence- phase 2
Time frame: post-training to post one-year maintenance
Change in SWAL-QOL- phase 1
Time frame: Pretraining to posttraining (after four weeks of intensive training)
Change in SWAL-QOL - phase 2
Time frame: post-training to post one-year maintenance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Michelle Troche, PhD principal investigator
Teachers College, Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Expiratory Muscle Strength Training + Cough Skill Training in people with Parkinson Disease and Dysphagia, run by Teachers College, Columbia University at 2 sites in United States.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Troche, PhD (212-678-3072, uadlab@tc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1 (time frame: Pretraining to posttraining (after four weeks of intensive training)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.