HealthyNCT07508059
High Resolution Pharyngeal Manometry (HRPM) Biofeedback
A study testing Swallowing Maneuvers and High Resolution Pharyngeal Manometry (HRPM) in people with Healthy, run by NYU Langone Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Swallowing Maneuvers and High Resolution Pharyngeal Manometry (HRPM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be independent community dwelling adults.
- Participants must be between the ages of 18-40 years old.
- Willingness to consent and participate in the study procedures.
- No reported dysphagia or difficulty swallowing evidenced by an EAT-10 Score <3.
Who cannot join
- Known structural or neurological causes of dysphagia (e.g., stroke, brain injury, or head/neck cancer).
- Recent or remote history of swallowing therapy; familiarity with swallowing maneuvers from relevant coursework as applicable (i.e., speech language pathology students).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claire Crossman contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Assessing the Impact of Biofeedback on Task Performance With Swallowing Maneuvers in Healthy Young Adults Using High Resolution Pharyngeal Manometry (HRPM)
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.
- Conditions
- Healthy
- Being tested
- Swallowing Maneuvers, High Resolution Pharyngeal Manometry (HRPM)
- Keywords
- Swallow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing ManeuversOther
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).
High Resolution Pharyngeal Manometry (HRPM)Diagnostic test
Also called Solar GI
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Swallowing Maneuvers; Diagnostic Test: High Resolution Pharyngeal Manometry (HRPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: Baseline (without HRPM), with HRPM (up to 2 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start19 Aug 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonja Molfenter, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508059
- Sponsor's protocol ID
- 25-01669
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Biofeedback on Task Performance With Swallowing Maneuvers in Healthy Young Adults Using High Resolution Pharyngeal Manometry (HRPM)
- ClinicalTrials.gov ID
- NCT07508059
- Acronym / sponsor ID
- 25-01669
- Conditions
- Healthy
- Keywords
- Swallow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swallowing Maneuvers with and without HRPM Biofeedback | Experimental | Other: Swallowing Maneuvers, Diagnostic Test: High Resolution Pharyngeal Manometry (HRPM)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must be independent community dwelling adults.
- Participants must be between the ages of 18-40 years old.
- Willingness to consent and participate in the study procedures.
- No reported dysphagia or difficulty swallowing evidenced by an EAT-10 Score <3.
Key exclusion criteria (2 listed)
- Known structural or neurological causes of dysphagia (e.g., stroke, brain injury, or head/neck cancer).
- Recent or remote history of swallowing therapy; familiarity with swallowing maneuvers from relevant coursework as applicable (i.e., speech language pathology students).
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 |
|---|---|---|
| Swallowing ManeuversSwallows 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). | Other | Swallowing Maneuvers with and without HRPM Biofeedback |
| High Resolution Pharyngeal Manometry (HRPM)Also: Solar GIA diagnostic tool using a catheter with closely spaced sensors to measure pressures and timing within the pharynx and upper esophageal sphincter (UES) during swallowing | Diagnostic test | Swallowing Maneuvers with and without HRPM Biofeedback |
Primary outcome
Change in pharyngeal contractile integral (PhCI) (mmHg) with and without visual biofeedback via HRPM
Time frame: Baseline (without HRPM), with HRPM (up to 2 minutes)
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
Change in pharyngoesophageal Segment (PES) opening duration (ms) with and without visual biofeedback via HRPM
Time frame: Baseline (without HRPM), with HRPM (up to 2 minutes)
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.
Change in PES pressure with visual biofeedback via HRPM with and without visual biofeedback via HRPM
Time frame: Baseline (without HRPM), with HRPM (up to 2 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Claire Crossman contact
Sonja Molfenter principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing Maneuvers and High Resolution Pharyngeal Manometry (HRPM) in people with Healthy, run by NYU Langone Health 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonja Molfenter (212-992-7694, Smm16@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pharyngeal contractile integral (PhCI) (mmHg) with and without visual biofeedback via HRPM (time frame: Baseline (without HRPM), with HRPM (up to 2 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.