Dysphagia Clinical Trial
Official title:
Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises
NCT number | NCT05080725 |
Other study ID # | 19-00860 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 24, 2022 |
Est. completion date | October 4, 2022 |
Verified date | February 2023 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to learn more about how exercise and protein supply affect swallow muscles. Twenty healthy older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Zoom. During each session, a series of swallow exercises will be performed following a demonstration from a trained speech-language pathologist. Participants will be referred to NYU Langone Health or White Plains Hospital, for a videofluoroscopic swallowing study, acoustic pharyngometry and measures of hand grip strength before and after the treatment protocol. Patients will be able to select their preferred site for swallow study completion. Results will inform the relationship between swallow exercises and pharyngeal muscles. All devices and exercises are established as safe and effective and are FDA approved.
Status | Completed |
Enrollment | 2 |
Est. completion date | October 4, 2022 |
Est. primary completion date | October 4, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 120 Years |
Eligibility | Inclusion Criteria: - Age 65 and older - SARC-F score of =4 - Functional hearing and vision status - Access to reliable internet connection - Availability of caregiver/family support and/or comfort with independent technology usage Exclusion Criteria: - Known structural or neurological causes of dysphagia - Not suitable to consume high levels of protein supplementation (i.e. moderate to severe kidney dysfunction) |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of pharyngeal constriction before intervention | 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention | Session 0 (Day 0 pre-intervention visit) | |
Primary | Measurement of pharyngeal constriction after intervention | 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention | Session 17 (9 week post-intervention visit) | |
Primary | Measurement of pharyngeal shortening before intervention | 2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention | Session 0 (Day 0 pre-intervention visit) | |
Primary | Measurement of pharyngeal shortening after intervention | 2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention | Session 17 (9 week post-intervention visit) | |
Secondary | Measurement of pharyngeal wall thickness before intervention | 2D lateral videofluoroscopic images will be used to measure wall thickness pre and post intervention | Session 0 (Day 0 pre-intervention visit) | |
Secondary | Measurement of pharyngeal wall thickness after intervention | 2D lateral videofluoroscopic images will be used to measure wall thickness pre and post intervention | Session 17 (9 week post-intervention visit) | |
Secondary | Measurement of pharyngeal volume before intervention | Acoustic Pharyngometry will be used to measure pharyngeal volume pre and post intervention. | Session 0 (Day 0 pre-intervention visit) | |
Secondary | Measurement of pharyngeal volume after intervention | Acoustic Pharyngometry will be used to measure pharyngeal volume pre and post intervention. | Session 17 (9 week post-intervention visit) |
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