CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
Passy Muir Valve +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06229639
NCT06229639N/ACompleted

Assessing the Safety of the Nocturnal Passy Muir Valve and Its Impact on Sleep Quality in an LTACH Setting

Gaylord Hospital, Inc·interventional·Posted Jan 29, 2024·Updated Mar 11, 2026

In Brief

A clinical study evaluating Passy Muir Valve and Tracheostomy Plug for Tracheostomy. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTracheostomy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 29, 2024
Enrollment StartJan 1, 2016
Primary CompletionJan 1, 2018
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 2.4 years ago

Interventions

Passy Muir Valvedevice

Tracheostomy Plugdevice