Deglutition DisordersNCT06465355
Effects of an Air Bolus on Primary Peristalsis
A study testing pharyngo-esophageal high-resolution manometry in people with Deglutition Disorders, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- pharyngo-esophageal high-resolution manometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subject with no history or present diagnosis of pharyngo-esophageal diseases or motility disorders
- Age 21 to 90 years
Who cannot join
- Under the age of 21
- Over the age of 90
- Presence of pharyngo-esophageal disease or motility disorders
- Pregnancy
- Lidocaine allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53086
About this study
Official title: The Role of Swallowing An Air Bolus on Primary Esophageal Peristalsis
Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
Read the detailed description
Study Procedures and Analyses
- All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study
- After application of local lidocaine, the high resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the pharynx and the esophagus. Affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the HRM catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure.
- Study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. There is a 30 second interval between swallows.
- Following completion of the study, the manometry catheter and the single lumen tube will be removed.
- The participant will also be instructed to resume their regular diet and activity.
- All the pressure recordings will be analyzed by two individuals in a blinded fashion.
The investigators will compare motility pressure metrics like striated esophageal muscle contractile integral, esophageal smooth muscle contractile integral, peristaltic wave velocity and esophageal clearance time to evaluate the potential differences in esophageal motility metrics when an air bolus is allowed to flow into the esophagus compared to those metrics when air is shunted out of the pharynx by a trans-nasal tube vented to the atmosphere.
Statistical analysis will be performed in a repeated measures technique comparing metrics with and without the pharyngeal shunt stopcock closed.
- Conditions
- Deglutition Disorders
- Being tested
- pharyngo-esophageal high-resolution manometry
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharyngo-esophageal high-resolution manometryProcedure or surgery
The high resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the pharynx and the esophagus. Affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the HRM catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure. 3. Study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. There is a 30 second interval between swallows.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Other | Pharyngo-esophageal high resolution manometry with affixed single-lumen, end-hole catheter wherein one end of the single lumen catheter is in the pharynx and the other is connected to an external stopcock to vent or not vent the pharynx to atmosphere during twenty dry swallows (10 vented, 10 unvented). Receives: Procedure: pharyngo-esophageal high-resolution manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
striated esophageal muscle contractile integral
Motility pressure metric to measure contractile vigor of the proximal esophagus in mmHg-cm-seconds
Measured: through study completion, an average of 1 year
smooth esophageal muscle contractile integral
Motility pressure metric to measure contractile vigor of the distal esophagus in mmHg-cm-seconds
Measured: through study completion, an average of 1 year
peristaltic wave velocity
average speed at which the primary peristaltic pressure wave traverses the esophagus in cm/second
Measured: through study completion, an average of 1 year
esophageal clearance time
time for the entire swallowed bolus to travers the esophagus in seconds
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start10 Oct 2019
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In healthy adults, determine the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Shaker, MD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465355
- Sponsor's protocol ID
- PRO00035855
- Status last verified
- Apr 2025
- First submitted
- 10 Jun 2024
- Last updated
- 28 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Swallowing An Air Bolus on Primary Esophageal Peristalsis
- ClinicalTrials.gov ID
- NCT06465355
- Acronym / sponsor ID
- PRO00035855
- Conditions
- Deglutition Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 18 Jun 2024 (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.
Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
Detailed description
Study Procedures and Analyses
- All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study
- After application of local lidocaine, the high resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the pharynx and the esophagus. Affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the HRM catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure.
- Study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. There is a 30 second interval between swallows.
- Following completion of the study, the manometry catheter and the single lumen tube will be removed.
- The participant will also be instructed to resume their regular diet and activity.
- All the pressure recordings will be analyzed by two individuals in a blinded fashion.
The investigators will compare motility pressure metrics like striated esophageal muscle contractile integral, esophageal smooth muscle contractile integral, peristaltic wave velocity and esophageal clearance time to evaluate the potential differences in esophageal motility metrics when an air bolus is allowed to flow into the esophagus compared to those metrics when air is shunted out of the pharynx by a trans-nasal tube vented to the atmosphere.
Statistical analysis will be performed in a repeated measures technique comparing metrics with and without the pharyngeal shunt stopcock closed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In healthy adults, determine the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | Other | Procedure: pharyngo-esophageal high-resolution manometryPharyngo-esophageal high resolution manometry with affixed single-lumen, end-hole catheter wherein one end of the single lumen catheter is in the pharynx and the other is connected to an external stopcock to vent or not vent the pharynx to atmosphere during twenty dry swallows (10 vented, 10 unvented). |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subject with no history or present diagnosis of pharyngo-esophageal diseases or motility disorders
- Age 21 to 90 years
Key exclusion criteria (5 listed)
- Under the age of 21
- Over the age of 90
- Presence of pharyngo-esophageal disease or motility disorders
- Pregnancy
- Lidocaine allergy
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 |
|---|---|---|
| pharyngo-esophageal high-resolution manometryThe high resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the pharynx and the esophagus. Affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the HRM catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure. 3. Study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. There is a 30 second interval between swallows. | Procedure or surgery | Healthy adults |
Primary outcome
striated esophageal muscle contractile integral
Time frame: through study completion, an average of 1 year
Motility pressure metric to measure contractile vigor of the proximal esophagus in mmHg-cm-seconds
smooth esophageal muscle contractile integral
Time frame: through study completion, an average of 1 year
Motility pressure metric to measure contractile vigor of the distal esophagus in mmHg-cm-seconds
peristaltic wave velocity
Time frame: through study completion, an average of 1 year
average speed at which the primary peristaltic pressure wave traverses the esophagus in cm/second
esophageal clearance time
Time frame: through study completion, an average of 1 year
time for the entire swallowed bolus to travers the esophagus in seconds
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharyngo-esophageal high-resolution manometry in people with Deglutition Disorders, run by Medical College of Wisconsin 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 28 Apr 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
striated esophageal muscle contractile integral (time frame: through study completion, an average of 1 year). The study lists 4 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 28 Apr 2025.