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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 is a clinical trial that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 18 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04139499
The ClinicalTrials.gov registry entry for NCT04139499 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Drug-induced sleep endoscopy (DISE) is the first listed.
NCT04139499 reports 0 study locations.
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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