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NCT01154322 · ClinicalTrials.gov registry record · NA
Pediatric Nasal Mask Usability Study
A NA study, sponsored by ResMed.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT01154322: Completed NA study, sponsored by ResMed.
NCT01154322 is a NA study that has completed, run by ResMed. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01154322, a NA study, has completed, sponsored by ResMed.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
Primary Outcome
Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe \>30). In clinical practice an AHI \<5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The out
Interventions
- DEVICE Pixi pediatric mask
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-11 |
| Phase | NA |
What the finished NCT01154322 record still lists
NCT01154322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Pixi pediatric mask is the first listed.
NCT01154322 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01154322 about?
NCT01154322 is a clinical study titled "Pediatric Nasal Mask Usability Study". The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
What is the current status of trial NCT01154322?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2010-06. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01154322?
The interventions under investigation include: Pixi pediatric mask (DEVICE).
Who is sponsoring clinical trial NCT01154322?
This trial is sponsored by ResMed, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01154322's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 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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