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NCT04139499 · ClinicalTrials.gov registry record
Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep
A clinical trial, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- 18
- Enrollment target
NCT04139499: Completed study, sponsored by University of Wisconsin, Madison.
NCT04139499 is a clinical trial that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04139499 has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- 18 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) is a major public health issue in both children and adults, present in 1-5% of children and 10-30% of adults. It is characterized by repeated episodes of airway obstruction during sleep, leading to brain arousal, sympathetic activation, oxygen desaturation, sleep fragmentation, and non-restorative sleep. Patients report daytime tiredness, insomnia, and morning headaches. Children with OSA experience daytime somnolence, difficulties at school, behavioral problems, enuresis, and reduced quality of life. If left untreated, OSA can lead to numerous complications including hypertension, cardiovascular disease, stroke, and insulin resistance. Sleep partners are also affected, with patients viewing their disorder as a burden and sleeping in separate rooms. Further, disease prevalence is increasing as obesity increases. Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. If used effectively and consistently, it can improve patient symptoms. However, adherence is generally poor, with patients experiencing physical discomfort, chest discomfort, and dry mouth. For those patients that cannot tolerate CPAP, surgical intervention is an option. In children, this typically starts with adenotonsillectomy. However, 20-75% of children will have persistent symptoms after adenotonsillectomy. In adults, anatomic factors including tonsil hypertrophy and redundant pharyngeal tissue can contribute to upper airway obstruction and may also necessitate higher pressures for effective CPAP treatment. Even if surgical intervention does not cure the OSA, it may make CPAP more tolerable and improve CPAP adherence. Sleep-related airway obstruction is a complex phenomenon potentially involving multiple anatomic levels. For patients with persistent symptoms despite initial therapy or intolerance to CPAP, further evaluation of the upper airway is clinically valuable. Polysomnography (PSG) is the gold standard for diagnosing OSA, but
Primary Outcome
Baseline pressure at different levels of obstruction in OSA participants will be measured by HRM. The aim is to determine if HRM can identify obstruction at the velopharynx, oropharynx, tongue base, and epiglottis as seen on DISE. obstruction at each site will be identified on DISE. Subject data will be divided into three groups for each site based on results from the DISE exam, which are currently used clinically: no obstruction (\<50% obstructed), partial obstruction (50-75% obstruction), or c
Interventions
- PROCEDURE Drug-induced sleep endoscopy (DISE)
- PROCEDURE High-resolution manometry (HRM):
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-01-16 |
| Est. Completion | 2021-05-05 |
What the finished NCT04139499 record still lists
NCT04139499 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Drug-induced sleep endoscopy (DISE) is the first listed.
NCT04139499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04139499 about?
NCT04139499 is a clinical study titled "Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep". Obstructive sleep apnea (OSA) is a major public health issue in both children and adults, present in 1-5% of children and 10-30% of adults. It is characterized by repeated episodes of airway obstruction during sleep, leading to brain arousal, sympathetic activation, oxygen desaturation, sleep fragme...
What is the current status of trial NCT04139499?
This trial is currently completed. The enrollment target is 18 participants. The study started on 2019-01-16. Estimated completion is 2021-05-05.
What interventions are being tested in trial NCT04139499?
The interventions under investigation include: Drug-induced sleep endoscopy (DISE) (PROCEDURE), High-resolution manometry (HRM): (PROCEDURE).
Who is sponsoring clinical trial NCT04139499?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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