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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-training to post one-year maintenance

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1

Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 2

Change in Penetration-Aspiration Scale (PAS) - phase 1

+1 more

Secondary outcome measures

Change in Cough expired volume - phase 1

Change in Cough expired volume - phase 2

Change in Maximum Expiratory Pressure - phase 1

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TelehealthExperimental Treatment1 Intervention

Group II: In-personActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,269 Total Patients Enrolled

Teachers College, Columbia UniversityLead Sponsor

24 Previous Clinical Trials

5,737 Total Patients Enrolled

Purdue UniversityOTHER

224 Previous Clinical Trials

72,644 Total Patients Enrolled

Media Library

Expiratory Muscle Strength Training + Cough Skill Training Clinical Trial Eligibility Overview. Trial Name: NCT05700825 — Phase 2

Parkinson's Disease Research Study Groups: In-person, Telehealth

Parkinson's Disease 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are virtual medical consultations secure for individuals?

"There is some evidence of safety associated with Telehealth, which has been assigned a rating of 2 on our scale. However, efficacy still needs to be determined through further clinical trials."

Answered by AI

Are senior citizens being accepted for participation in this experiment?

"Patients hoping to join this study must be between 50 and 90 years old. Alternatively, younger patients can look into the 27 trials available for those under 18 and seniors over 65 have a selection of 509 studies to choose from."

Answered by AI

Is there any remaining capacity for enrolment in this experiment?

"The clinicaltrials.gov entry for this medical trial indicates that the study is not presently recruiting participants. The trial was initiated on August 11th 2022 and last amended in January 17th 2023, however 517 other studies require volunteers at present."

Answered by AI

To whom is recruitment open for this experiment?

"This clinical trial seeks 120 individuals aged 50 to 90 with a Parkinson's disease diagnosis that has been confirmed by a fellowship-trained Movement Disorders neurologist. In addition, participants must have airway protective deficits (penetration-aspiration score >3) and/or dystussia (PEFR≤4.1 L/s), not be undergoing exercise-based swallowing therapy at the time of enrollment in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rehabilitation of Airway Protection in Parkinson's Disease

Michelle Troche 2023. "Rehabilitation of Airway Protection in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05700825.

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