NCT06229639

Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Gaylord Hospital, Inc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Currently, the PMV has only been approved by the FDA for daytime use. As such, it is encouraged to remove speaking valves at night. However, there is minimal evidence indicating that the use of speaking valves during nighttime poses a significant risk. Studies focusing on the safety of the PMV for nocturnal use reported no significant effects on patients' well-being, including no significant oxygen desaturations or major cardiopulmonary events. This was shown in pediatric patients and adult patients admitted to an ICU. While promising, these findings are still limited, and additional evidence is needed to demonstrate the safety of nocturnal PMV use before larger studies can be conducted. It was anecdotally witnessed that patients frequently sleep during the day with the PMV in place, suffering no recourse to adverse events. The primary objective of this study was to determine if nocturnal PMV use can be considered safe within the long-term acute care hospital setting and its impact on sleep quality

Conditions

• Tracheostomy

Interventions

Type	Name	Description
DEVICE	Passy Muir Valve
DEVICE	Tracheostomy Plug

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-01-01
• Completion: 2018-02-01
• First posted: 2024-01-29
• Last updated: 2026-03-11
• Results posted: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study