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High-resolution Pharyngeal Manometry for Obstructive Sleep Apnea
N/A
Waitlist Available
Led By David T. Kent, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected during operative procedure, taking about 15 minutes.
Awards & highlights
Study Summary
This trial is testing a new diagnostic device to see if it's effective. The device is not commonly used yet and researchers want to see if it could be helpful in the future.
Eligible Conditions
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected during operative procedure, taking about 15 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during operative procedure, taking about 15 minutes.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharyngeal pressure differentials
Video endoscopy of pharyngeal collapse
Secondary outcome measures
Patient tolerance of catheter
Trial Design
1Treatment groups
Experimental Treatment
Group I: Investigational DeviceExperimental Treatment1 Intervention
Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) with the Solar GI High Resolution pharyngeal Manometry system.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High-resolution pharyngeal manometry catheter
2017
N/A
~60
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
861 Previous Clinical Trials
672,743 Total Patients Enrolled
David T. Kent, MDPrincipal InvestigatorVanderbilt University Medical Center
3 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have medical conditions that make it unsafe for you to receive sedation, as determined by your medical history and examination.You have had surgery on your throat or the roof of your mouth, except for having your tonsils removed.You have a very blocked nose that makes it hard to do certain medical tests.You have been diagnosed with obstructive sleep apnea, which means you stop breathing or have shallow breathing frequently during sleep.You are scheduled to undergo a sleep study to assess your throat anatomy.You have had an allergic reaction to eggs in the past, based on your medical history or what you have told the doctor.You have received radiation treatment to your head or neck in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to participate in this research effort?
"Affirmative. Clinicaltrials.gov states that this experiment is actively searching for volunteers and began on December 11th 2017. Last updated on October 28th 2022, the research team needs to recruit 75 participants from a single site."
Answered by AI
How many participants are engaged with this experiment?
"Confirmed. Clinicaltrials.gov cites that this medical study, which was originally announced on December 11th 2017, is actively recruiting patients. Approximately 75 individuals are sought out at a single clinical trial site to participate in the research."
Answered by AI
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