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NCT06229639 · ClinicalTrials.gov registry record · NA
Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting
A NA study, sponsored by Gaylord Hospital.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT06229639: Completed NA study, sponsored by Gaylord Hospital.
NCT06229639 is a NA study that has completed, run by Gaylord Hospital. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06229639, a NA study, has completed, sponsored by Gaylord Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
Limited research has been done to assess the safety of PMV use during sleep. One prospective study completed by Diez-Gross, et al in 2007 looked at 10 male subjects recorded on two consecutive nights, one night with PMV on and one night with PMV off. All recordings took place in a monitored setting. The variables studied included O2 saturation, apnea index, apnea - hypopnea index, and nursing reports. Conclusion was PMV use for one night in seriously ill tracheostomy patients was not associated with respiratory distress or cardiac issues.
Primary Outcome
Measures the number of contractions of the heart per minute (bpm). The measurement is an average calculated by dividing the sum of all three time points by 3. Their respective groups were collected at three time points.
Interventions
- DEVICE Passy Muir Valve
- DEVICE Tracheostomy Plug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-02 |
| Phase | NA |
What the finished NCT06229639 record still lists
NCT06229639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Passy Muir Valve is the first listed.
NCT06229639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06229639 about?
NCT06229639 is a clinical study titled "Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting". Limited research has been done to assess the safety of PMV use during sleep. One prospective study completed by Diez-Gross, et al in 2007 looked at 10 male subjects recorded on two consecutive nights, one night with PMV on and one night with PMV off. All recordings took place in a monitored setting....
What is the current status of trial NCT06229639?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2016-01. Estimated completion is 2018-02.
What interventions are being tested in trial NCT06229639?
The interventions under investigation include: Passy Muir Valve (DEVICE), Tracheostomy Plug (DEVICE).
Who is sponsoring clinical trial NCT06229639?
This trial is sponsored by Gaylord Hospital, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06229639's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 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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