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NCT02489591 · ClinicalTrials.gov registry record · NA
Characterizing Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea
A NA study of Sleep Apnea, Obstructive, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT02489591: Completed NA study of Sleep Apnea, Obstructive, sponsored by Brigham and Women's Hospital.
NCT02489591 is a NA study of Sleep Apnea, Obstructive that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 25 participants, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02489591, a NA study of Sleep Apnea, Obstructive, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Obstructive Sleep Apnea (OSA) is characterized by collapse of one or more pharyngeal structures during sleep (velum, tongue base, lateral walls, epiglottis). Structure-specific therapies for OSA have emerged as alternatives to positive airway pressure (PAP). Oral appliance (OA) therapy is increasingly being indicated for OSA treatment, although a complete response occurs in approximately 50% of patients. In general, OA devices are designed to maintain the mandible and/or tongue in a protruded posture during sleep, preventing upper airway obstruction. Limited studies in awake or sedated patients have demonstrated the effects of mandibular advancement on aspects of pharyngeal structure and function. The objective of the proposed research is to fully characterize upper airway collapse in OSA patients during natural sleep and use this information to understand why some patients appear to exhibit a large improvement in pharyngeal collapsibility whereas others do not.
Primary Outcome
The passive pressure-flow relationship is characterized by the critical closing pressure (Pcrit) , and the ventilatory flow at atmospheric pressure ( V passive). Pcrit and V passive will be determined using the standard 5-breath CPAP drop method. The change in collapsibility will be compared across subgroups defined by the site of collapse measured using sleep-endoscopy. Patients will sleep supine for this measurement.
Conditions Studied
Interventions
- DEVICE Oral appliance
- DEVICE BluePro oral appliance
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2015-07-14 |
| Est. Completion | 2018-11 |
| Phase | NA |
What the finished NCT02489591 record still lists
NCT02489591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 2 interventions - of which Oral appliance is the first listed.
NCT02489591 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02489591 about?
NCT02489591 is a clinical study titled "Characterizing Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea". Obstructive Sleep Apnea (OSA) is characterized by collapse of one or more pharyngeal structures during sleep (velum, tongue base, lateral walls, epiglottis). Structure-specific therapies for OSA have emerged as alternatives to positive airway pressure (PAP). Oral appliance (OA) therapy is increasing...
What is the current status of trial NCT02489591?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2015-07-14. Estimated completion is 2018-11.
What conditions does trial NCT02489591 study?
This clinical trial studies the following conditions: Sleep Apnea, Obstructive.
What interventions are being tested in trial NCT02489591?
The interventions under investigation include: Oral appliance (DEVICE), BluePro oral appliance (DEVICE).
Who is sponsoring clinical trial NCT02489591?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02489591 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Apnea, Obstructive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02489591's enrollment target sits among peer trials
25 38th of 45 higher than 8 of 45 other Sleep Apnea, Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Apnea, Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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