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Airway Protection Rehabilitation for Parkinson's Disease

Phase 2
Recruiting
Led By Michelle Troche, PhD
Research Sponsored by Teachers College, Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-training to post one-year maintenance
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at a novel treatment to improve airway protection in Parkinson’s Disease, which is the leading cause of death in PD. It will look at if this treatment works better in person or via telehealth and how patient burden and adherence affect outcomes.

Who is the study for?
This trial is for people aged 50-90 with Parkinson's Disease who have trouble swallowing or coughing but aren't currently getting therapy for it. They must be diagnosed by a specialist and can't have other neurological disorders, recent smoking history, breathing diseases, severe depression or dementia.
What is being tested?
The study tests whether training to strengthen the muscles used in breathing out and coughing helps protect the airway better than usual care. It compares results of doing these exercises in-person versus via telehealth to see which is more effective.
What are the potential side effects?
Potential side effects may include discomfort from exercising the expiratory muscles and possible irritation from capsaicin if used during assessments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-training to post one-year maintenance
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-training to post one-year maintenance for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Penetration-Aspiration Scale (PAS) - phase 1
Change in Penetration-Aspiration Scale (PAS) - phase 2
Secondary study objectives
Change in SWAL-QOL - phase 2
Change in SWAL-QOL- phase 1
Change in Treatment Adherence- phase 2
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TelehealthExperimental Treatment1 Intervention
Group II: In-personActive Control1 Intervention

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,568 Total Patients Enrolled
27 Trials studying Dementia
199,326 Patients Enrolled for Dementia
Teachers College, Columbia UniversityLead Sponsor
26 Previous Clinical Trials
5,952 Total Patients Enrolled
Purdue UniversityOTHER
233 Previous Clinical Trials
71,253 Total Patients Enrolled
Michelle Troche, PhDPrincipal InvestigatorTeachers College, Columbia University

Media Library

Expiratory Muscle Strength Training + Cough Skill Training Clinical Trial Eligibility Overview. Trial Name: NCT05700825 — Phase 2
Dementia Research Study Groups: In-person, Telehealth
Dementia Clinical Trial 2023: Expiratory Muscle Strength Training + Cough Skill Training Highlights & Side Effects. Trial Name: NCT05700825 — Phase 2
Expiratory Muscle Strength Training + Cough Skill Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05700825 — Phase 2
~64 spots leftby Sep 2027
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