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NCT02693977 · ClinicalTrials.gov registry record
Use of Sleep Endoscopy to Predict Outcomes of Pediatric Adenotonsillectomy
A clinical trial, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- 347
- Enrollment target
NCT02693977: Completed study, sponsored by Oregon Health and Science University.
NCT02693977 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 347 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02693977 has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- 347 participants
- Enrollment target
Study Summary
Pediatric obstructive sleep apnea (OSA) is associated with heavy snoring and brief pauses in breathing during sleep. It affects at least 1-3% of the general pediatric population with greater prevalence among certain high risk groups such as children with obesity, Down syndrome, craniofacial anomalies, or neuromuscular disorders. Several studies have shown that, even after having adenotonsillectomy (AT), approximately 30% of children continue to struggle with OSA. They further found that older children (age \> 7 yrs), obesity, and high pre-operative OSA severity were all risk factors contributing to residual OSA. Despite these known risk factors, the ability to predict each individual patient's risk of residual OSA after tonsil surgery is difficult. Determining what tool will best predict residual OSA is an important step towards more effective post-surgery OSA management. The purpose of this study is to determine whether sleep endoscopy can predict whether their AT will be successful as a treatment for OSA. Our hypothesis is that subjects with multiple areas of obstruction in addition to large tonsils will be more likely to have residual OSA after AT. Sleep endoscopy is a procedure performed during drug-induced sleep that involves passing a flexible endoscope through the subject's nose into the back of the throat to look for sources of obstruction while breathing spontaneously. This will be a prospective cohort study examining subjects between the ages of 2 and 18 who are having AT for treatment of obstructive sleep apnea (OSA) and are considered high risk for residual OSA after surgery. High risk will be defined based on the following criteria: obesity, Down syndrome, African American race, severe baseline OSA, and age \> 7 yrs. Eligible subjects will be recruited from the pediatric otolaryngology clinic at the time of initial evaluation for AT. Subjects will undergo a sleep endoscopy under moderate sedation at the time of AT. All patients will be asked to comple
Primary Outcome
Polysomnography results
Interventions
- PROCEDURE Sleep Endoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2015-02-01 |
| Est. Completion | 2023-03-31 |
What the finished NCT02693977 record still lists
NCT02693977 is an observational study that tracks outcomes without assigning an intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Sleep Endoscopy is the first listed.
NCT02693977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02693977 about?
NCT02693977 is a clinical study titled "Use of Sleep Endoscopy to Predict Outcomes of Pediatric Adenotonsillectomy". Pediatric obstructive sleep apnea (OSA) is associated with heavy snoring and brief pauses in breathing during sleep. It affects at least 1-3% of the general pediatric population with greater prevalence among certain high risk groups such as children with obesity, Down syndrome, craniofacial anomalie...
What is the current status of trial NCT02693977?
This trial is currently completed. The enrollment target is 347 participants. The study started on 2015-02-01. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT02693977?
The interventions under investigation include: Sleep Endoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT02693977?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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