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NCT01061476 · ClinicalTrials.gov registry record · Phase 1
Sleep Apnea Treatment With Expiratory Resistance(Provent™)
A Phase 1 study of Sleep Apnea, Obstructive, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01061476: Completed Phase 1 study of Sleep Apnea, Obstructive, sponsored by Johns Hopkins University.
NCT01061476 is a Phase 1 study of Sleep Apnea, Obstructive that has completed, run by Johns Hopkins University. The registered enrollment target is 12 participants, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01061476, a Phase 1 study of Sleep Apnea, Obstructive, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the current study is to examine how well the Provent™ device treats OSA with particular attention to the how the it may treat sleep apnea and who may most likely benefit from the use of this treatment.
Primary Outcome
The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI \> 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and \> 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).
Conditions Studied
Interventions
- DEVICE Treatment sleep study (Provent™ device used)
- OTHER Baseline sleep study (No device)
- OTHER Physiology sleep study (Provent™ on/off)
Study Locations (1)
Maryland
- Johns Hopkins Asthma and Allergy Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT01061476 record still lists
NCT01061476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 3 interventions - of which Treatment sleep study (Provent™ device used) is the first listed.
NCT01061476 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01061476 about?
NCT01061476 is a clinical study titled "Sleep Apnea Treatment With Expiratory Resistance(Provent™)". Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been dev...
What is the current status of trial NCT01061476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-01. Estimated completion is 2011-01.
What conditions does trial NCT01061476 study?
This clinical trial studies the following conditions: Sleep Apnea, Obstructive.
What interventions are being tested in trial NCT01061476?
The interventions under investigation include: Treatment sleep study (Provent™ device used) (DEVICE), Baseline sleep study (No device) (OTHER), Physiology sleep study (Provent™ on/off) (OTHER).
Who is sponsoring clinical trial NCT01061476?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01061476 being conducted?
This trial has 1 study location across Maryland. 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 NCT01061476's enrollment target sits among peer trials
12 45th of 45 higher than 1 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.
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