Parkinson's DiseasePhase 2NCT02927691

Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial

A Phase 2 study testing EMST and smTAP in people with Parkinson's Disease and Dysphagia, run by Teachers College, Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 90 years
Conditions the study is for: Parkinson's Disease, Dysphagia, Dystussia
What is being tested?: EMST and smTAP
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: Sep 2016to Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 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)
Difficulty swallowing
Not actively receiving swallowing therapy.

Who cannot join

Other neurological disorders (e.g., multiple sclerosis, stroke, 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

Trial locations and contacts

1 site in 1 country.

United States1 site

Teachers College, Columbia University
New York, New York, 10027

Other trials in United States

About this study

Currently, there are no efficacious behavioral treatment approaches to address uncompensated aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD). This is of particular public health concern given that aspiration pneumonia is the leading cause of death in persons with PD. The overarching aim of the proposed study is to determine the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate the results will lead to reductions in the risks associated with airway protective deficits.

Read the detailed description

Study Rationale:

Aspiration pneumonia is a leading cause of death in persons with Parkinson's disease (PD). One of the main reasons people with PD develop aspiration pneumonia is that they often have both swallowing dysfunction (dysphagia) and cough dysfunction (dystussia). Because of this, if food or liquid enters the airway, a cough is not elicited and the material remains in the airway (silent aspiration). It is then possible for the material to enter the lungs resulting in an infection called aspiration pneumonia. Currently, there are no tested treatment approaches that specifically target silent aspiration.

Hypothesis:

The goal of this study is to determine how well two different rehabilitation treatments, expiratory muscle strength training (EMST) and sensorimotor treatment for airway protection (smTAP), work to improve cough and swallowing function in persons with PD and dysphagia.

Study Design:

This study will include two participant groups; one group will receive EMST and the other will receive smTAP. There will be initial baseline testing of swallowing, coughing, respiratory, and laryngeal function. The investigators will also measure the participants' perception of their cough and swallowing problem. Then, participants will be randomly assigned (much like the flip of a coin) to either the EMST or smTAP training groups. The participants will be further randomized to receive immediate training or delayed training where there is a 5-week wait to start with a second baseline performed at the end of the 5-week delay. Once training is complete the participants will once again complete measures of swallowing, coughing, respiratory and laryngeal function.

Impact on Diagnosis/Treatment of Parkinson's Disease:

The investigators anticipate that this study will assist in better understanding what treatments work best to improve swallowing and cough in people with PD; resulting in an immediate shift in the clinical management of swallowing and cough dysfunction in PD. The investigators also believe that participants will have improvements in swallowing and cough function; therefore, reducing the risk of aspiration pneumonia.

Conditions: Parkinson's Disease, Dysphagia, Dystussia
Being tested: EMST, smTAP
Keywords: Rehabilitation, Parkinson's disease, Swallowing, Cough, Dysphagia, Dystussia
Medical subject headings: Parkinson Disease, Deglutition Disorders, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EMSTDevice
smTAPBehavioural

Study groups in NCT02927691
Study group	Role	What they receive
Immediate Treatment	Experimental	Participants will begin treatment immediately following baseline testing. Receives: Device: EMST; Behavioral: smTAP
Delayed Treatment	Other	Following baseline testing, participants will receive no treatment for five weeks, then begin treatment immediately following a second baseline testing session. Receives: Device: EMST; Behavioral: smTAP

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Voluntary Cough Peak Flow
Peak expiratory flow rate (PEFR) was measured before (baseline) and after 5 weeks of treatment with EMST and smTAP.
Measured: Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Jun 2021

First posted7 Oct 2016 (estimated)
Study startSep 2016
Primary completionJun 2021
Study completionJun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinson's 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02927691
Sponsor's protocol ID: 542528
Status last verified: Dec 2023
First submitted: 13 Sep 2016
Last updated: 22 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.
PubMed 36345090

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
ClinicalTrials.gov ID: NCT02927691
Acronym / sponsor ID: 542528
Conditions: Parkinson's Disease, Dysphagia, Dystussia
Keywords: Rehabilitation, Parkinson's disease, Swallowing, Cough, Dysphagia, Dystussia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Teachers College, Columbia UniversityUniversity, hospital or other
Collaborators: Michael J. Fox Foundation for Parkinson's Research, University of Florida
Study start: Sep 2016
Primary completion: Jun 2021 (actual)
Study completion: Jun 2021 (actual)
First posted: 7 Oct 2016 (estimated)
Results: Posted 22 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Rationale:

Hypothesis:

Study Design:

Impact on Diagnosis/Treatment of Parkinson's Disease:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Immediate Treatment	Experimental	Device: EMST, Behavioral: smTAPParticipants will begin treatment immediately following baseline testing.
Delayed Treatment	Other	Device: EMST, Behavioral: smTAPFollowing baseline testing, participants will receive no treatment for five weeks, then begin treatment immediately following a second baseline testing session.

Who may qualify

Ages: 45 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosed with PD (Hoehn and Yahr Stages II-IV)
Difficulty swallowing
Not actively receiving swallowing therapy.

Key exclusion criteria (6 listed)

Other neurological disorders (e.g., multiple sclerosis, stroke, 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
EMST	Device	Delayed Treatment, Immediate Treatment
smTAP	Behavioural	Delayed Treatment, Immediate Treatment

Primary outcome

Change in Voluntary Cough Peak Flow
Time frame: Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks)
Peak expiratory flow rate (PEFR) was measured before (baseline) and after 5 weeks of treatment with EMST and smTAP.

Results and safety

Results posted to the registry on 22 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Expiratory Muscle Strength Training (EMST)	34	30
Sensorimotor Training for Airway Protection (smTAP)	31	28

Primary outcome: Change in Voluntary Cough Peak Flow

Time frame: Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks). Least squares mean (Full Range). Unit: l/s

Measure	EMST n = 34	smTAP n = 31
Value	0.17 (-2.32 to 3.85)	0.51 (-1.07 to 5.82)

Adverse events

Time frame: Adverse events were assessed from start to finish of the study. Therefore, adverse events were assessed from baseline through study completion for each participant - which was a total of (on average) 1.5 months. In other words - adverse events were assessed for all assessment visits (before and after treatment) and for all treatment sessions and the treatment period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EMST	0 of 34 (0%)	0 of 34 (0%)	0 of 34
smTAP	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Limitations and caveats (from the sponsor): Treatment adherence to the home program was measured via patient logs, which have potential to be unreliable. Another limitation is that capsaicin is not immediately available to clinicians, which can limit translation of our findings to clinical settings. Though this study included patients with mild to severe Parkinson's disease and dysphagia, it will be necessary to study whether these findings are replicated in a larger cohort of patients with severe Parkinson's disease and dysphagia.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36345090Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EMST and smTAP in people with Parkinson's Disease and Dysphagia, run by Teachers College, Columbia University at 1 site 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 3 inclusion and 6 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Voluntary Cough Peak Flow (time frame: Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks)). 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 NCT02927691, which also lists 1 linked publication.

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 22 Dec 2023.