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The purpose of this study is to quantify the added benefit of visual biofeedback from High Resolution Pharyngeal Manometry (HRPM) for swallowing rehabilitation. Primary aims including assessing changes in swallowing biomechanics (pressure generation, timing) during swallow maneuvers with and without HRPM visual biofeedback. Secondary aim includes participant attitudes related to visual biofeedback and the experience of HRPM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Swallowing Maneuvers with and without HRPM Biofeedback | Experimental | Participants will then undergo a 2-minute period of acclimation with the catheter in place prior to initiating the swallowing protocol and turning on the video biofeedback. Participants will then complete swallowing maneuvers, with 20 seconds between each swallow. The duration of the procedure from catheter placement to removal will be approximately 5-8 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swallowing Maneuvers | Other | Swallows will include 5 regular-effort saliva swallows (+/- visual biofeedback), 5 effortful saliva swallows (+/- visual biofeedback), 5 mendelsohn maneuver swallows (+/- visual biofeedback), and 5 masako or tongue hold maneuver swallows (+/- visual biofeedback). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pharyngeal contractile integral (PhCI) (mmHg) with and without visual biofeedback via HRPM | Pharyngeal contractile integral, a product of mean pharyngeal contractile amplitude, length, and duration. Low PhCI (< 100-150 mmHg·s·cm): Indicates hypo-contractility or weakness while High PhCI (> 200-300+ mmHg·s·cm): Represents stronger contraction strength | Baseline (without HRPM), with HRPM (up to 2 minutes) |
| Change in pharyngoesophageal Segment (PES) opening duration (ms) with and without visual biofeedback via HRPM | Measures the duration of Upper Esophageal Sphincter (UES) opening in milliseconds. Short Duration (<300ms) correlates with upper esophageal sphincter dysfunction, reduced laryngeal elevation, and poor pharyngeal contraction. | Baseline (without HRPM), with HRPM (up to 2 minutes) |
| Change in PES pressure with visual biofeedback via HRPM with and without visual biofeedback via HRPM | Baseline (without HRPM), with HRPM (up to 2 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Molfenter | Contact | 212-992-7694 | Smm16@nyu.edu | |
| Claire Crossman | Contact | Cmc9512@nyu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sonja Molfenter | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request immediately following publication, no end date, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: smm16@nyu.edu. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Immediately following publication. No end date.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to smm16@nyu.edu. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| High Resolution Pharyngeal Manometry (HRPM) | Diagnostic Test | A diagnostic tool using a catheter with closely spaced sensors to measure pressures and timing within the pharynx and upper esophageal sphincter (UES) during swallowing |
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