Obstructive Sleep ApneaNCT03198416
Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM
A study testing High-resolution pharyngeal manometry catheter in people with Obstructive Sleep Apnea, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This is a single-arm study involving the use of a high resolution manometry (HRM) diagnostic device that is not utilized in any clinical decision-making processes. All patients scheduled for DISE as part of their regular clinical care will be screened for enrollment via described inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- High-resolution pharyngeal manometry catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 24 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (≥18 years old)
- A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr
- Intolerant of continuous positive airway pressure (CPAP) therapy due to physical or psychosocial limitations as determined by PI
- Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy
Who cannot join
- Patient is unable to consent for research due to a pre-existing neurologic condition as determined by PI
- Patient is unable to consent for research due to language barriers
- Patient has a history of egg allergy as determined by history or self- report
- Patient is pregnant as determined by patient report or preoperative anesthesia evaluation
- Cardiopulmonary or other medical conditions precluding safe sedation as determined by clinical history and exam
- History of palatal or pharyngeal airway surgery except tonsillectomy as determined by clinical history and exam
- History of radiation treatment to the head or neck as determined by clinical history and/or exam
- Severe nasal airway obstruction preventing simultaneous flexible nasopharyngoscopy and manometry probe insertion as determined by physical exam
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Assessment Of Pharyngeal Anatomy In Obstructive Sleep Apnea With High Resolution Manometry
This is a single-arm study involving the use of a high resolution manometry (HRM) diagnostic device that is not utilized in any clinical decision-making processes. All patients scheduled for DISE as part of their regular clinical care will be screened for enrollment via described inclusion and exclusion criteria.
Read the detailed description
High-resolution pharyngeal manometry (HRM) is a diagnostic technique that has the potential to objectively measure pharyngeal collapse patterns in obstructive sleep apnea (OSA) during sedation as well as natural sleep. The purpose of this study is to assess the utility of HRM in objectively mapping patterns of pharyngeal collapse observed during drug-induced sleep endoscopy (DISE). Quantifying pharyngeal collapse patterns that occur during sedation and in natural sleep may significantly impact the selection and success of surgical treatments, as well as surgical outcome assessment.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- High-resolution pharyngeal manometry catheter
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution pharyngeal manometry catheterDevice
The system is a widely-used tool in gastrointestinal medicine for high resolution mapping of pressures within tubular organs.The device will be deployed trans-nasally into the pharyngeal and esophageal lumen in exactly the same fashion as is done for motility studies.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Experimental | Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) with the Solar GI High Resolution pharyngeal Manometry system. Receives: Device: High-resolution pharyngeal manometry catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharyngeal pressure differentials
A high-resolution pharyngeal manometry catheter will be used to capture air pressure data in millimeters of mercury at 0.8mm intervals throughout the pharynx and proximal esophagus during the drug-induced sleep endoscopy procedure. This data will be used to generate maps of pressure data over time.
Measured: Collected during operative procedure, taking about 15 minutes.
Video endoscopy of pharyngeal collapse
Video from the flexible nasopharyngoscopy exam conducted during the drug-induced sleep endoscopy will be recorded and time-synched to the high-resolution pharyngeal manometry catheter output. The video results will be graded by a trained reviewer using a validated scoring system called the VOTE classification. The VOTE system is a subjective scoring system based on video endoscopy that scores the degree and configuration of airway obstruction related to the velum (soft palate), oropharyngeal lateral walls, tongue base, and epiglottis. The VOTE classification results will be compared to the pressure catheter results to examine for correlations.
Measured: Collected during operative procedure, the video endoscopy will take about 15 minutes.
Secondary outcomes (2)
Patient tolerance of catheter
Patient comfort as indicated by pre operative pain survey
Measured: Completed pre-operatively, after catheter insertion, taking less than 5 minutes.
Patient tolerance of catheter
Patient comfort as indicated by post operative pain survey
Measured: Completed at follow up visit about 1 week post-operative, taking less than 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start11 Dec 2017
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients who meet eligiblity will undergo HRM at the same time as the operative DISE procedure.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kent, Vanderbilt University Medical Center
- Investigators
- David T. Kent, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198416
- Sponsor's protocol ID
- 170755
- Status last verified
- Jan 2024
- First submitted
- 11 Jun 2017
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kent DT, Scott WC, Ye C, Fabbri D. Objective Pharyngeal Phenotyping in Obstructive Sleep Apnea With High-Resolution Manometry. Otolaryngol Head Neck Surg. 2023 Jul;169(1):164-175. doi: 10.1002/ohn.257. Epub 2023 Jan 29.
PubMed 36939475
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Pharyngeal Anatomy In Obstructive Sleep Apnea With High Resolution Manometry
- ClinicalTrials.gov ID
- NCT03198416
- Acronym / sponsor ID
- 170755
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 26 Jun 2017 (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.
This is a single-arm study involving the use of a high resolution manometry (HRM) diagnostic device that is not utilized in any clinical decision-making processes. All patients scheduled for DISE as part of their regular clinical care will be screened for enrollment via described inclusion and exclusion criteria.
Detailed description
High-resolution pharyngeal manometry (HRM) is a diagnostic technique that has the potential to objectively measure pharyngeal collapse patterns in obstructive sleep apnea (OSA) during sedation as well as natural sleep. The purpose of this study is to assess the utility of HRM in objectively mapping patterns of pharyngeal collapse observed during drug-induced sleep endoscopy (DISE). Quantifying pharyngeal collapse patterns that occur during sedation and in natural sleep may significantly impact the selection and success of surgical treatments, as well as surgical outcome assessment.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients who meet eligiblity will undergo HRM at the same time as the operative DISE procedure.
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: High-resolution pharyngeal manometry catheterConsented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) with the Solar GI High Resolution pharyngeal Manometry system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old)
- A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr
- Intolerant of continuous positive airway pressure (CPAP) therapy due to physical or psychosocial limitations as determined by PI
- Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy
Key exclusion criteria (8 listed)
- Patient is unable to consent for research due to a pre-existing neurologic condition as determined by PI
- Patient is unable to consent for research due to language barriers
- Patient has a history of egg allergy as determined by history or self- report
- Patient is pregnant as determined by patient report or preoperative anesthesia evaluation
- Cardiopulmonary or other medical conditions precluding safe sedation as determined by clinical history and exam
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 |
|---|---|---|
| High-resolution pharyngeal manometry catheterThe system is a widely-used tool in gastrointestinal medicine for high resolution mapping of pressures within tubular organs.The device will be deployed trans-nasally into the pharyngeal and esophageal lumen in exactly the same fashion as is done for motility studies. | Device | Investigational Device |
Primary outcome
Pharyngeal pressure differentials
Time frame: Collected during operative procedure, taking about 15 minutes.
A high-resolution pharyngeal manometry catheter will be used to capture air pressure data in millimeters of mercury at 0.8mm intervals throughout the pharynx and proximal esophagus during the drug-induced sleep endoscopy procedure. This data will be used to generate maps of pressure data over time.
Video endoscopy of pharyngeal collapse
Time frame: Collected during operative procedure, the video endoscopy will take about 15 minutes.
Video from the flexible nasopharyngoscopy exam conducted during the drug-induced sleep endoscopy will be recorded and time-synched to the high-resolution pharyngeal manometry catheter output. The video results will be graded by a trained reviewer using a validated scoring system called the VOTE classification. The VOTE system is a subjective scoring system based on video endoscopy that scores the degree and configuration of airway obstruction related to the velum (soft palate), oropharyngeal lateral walls, tongue base, and epiglottis. The VOTE classification results will be compared to the pressure catheter results to examine for correlations.
2 secondary outcomes
Patient tolerance of catheter
Time frame: Completed pre-operatively, after catheter insertion, taking less than 5 minutes.
Patient tolerance of catheter
Time frame: Completed at follow up visit about 1 week post-operative, taking less than 5 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 36939475Kent DT, Scott WC, Ye C, Fabbri D. Objective Pharyngeal Phenotyping in Obstructive Sleep Apnea With High-Resolution Manometry. Otolaryngol Head Neck Surg. 2023 Jul;169(1):164-175. doi: 10.1002/ohn.257. Epub 2023 Jan 29.
- Individual participant dataSharing planned: Undecided
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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.
David T. Kent, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-resolution pharyngeal manometry catheter in people with Obstructive Sleep Apnea, run by Vanderbilt University Medical Center 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 8 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: finished, as of the sponsor's last update on 26 Jan 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharyngeal pressure differentials (time frame: Collected during operative procedure, taking about 15 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198416, which also lists 1 linked publication.
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 26 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.