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NCT01554527 · ClinicalTrials.gov registry record · NA
Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT01554527: Completed NA study, sponsored by University of Michigan.
NCT01554527 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01554527, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.
Primary Outcome
The sum of the T-scores of The Conners' Parent Rating Scales (CPRS-R:L, ADHD index) and the Child Behavior Checklist (CBCL, Attention Deficit/Hyperactivity Problems) are used to construct the primary study outcome measure Behavioral Index. Behavioral index is a T score (adjusted for age and gender) with a range of "\<10" to "\>90" - where higher scores mean worse behavior and lower scores mean better behavior, so a negative change score represents an improvement in behavior. T-scores with a mean
Interventions
- PROCEDURE CPAP treatment
- OTHER No CPAP treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2012-03 |
| Est. Completion | 2017-10-29 |
| Phase | NA |
What the finished NCT01554527 record still lists
NCT01554527 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which CPAP treatment is the first listed.
NCT01554527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01554527 about?
NCT01554527 is a clinical study titled "Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children". Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB...
What is the current status of trial NCT01554527?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2012-03. Estimated completion is 2017-10-29.
What interventions are being tested in trial NCT01554527?
The interventions under investigation include: CPAP treatment (PROCEDURE), No CPAP treatment (OTHER).
Who is sponsoring clinical trial NCT01554527?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01554527's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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