Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting (NCT06229639) | Clinical Trial Compass
CompletedNot Applicable
Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting
United States33 participantsStarted 2016-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient has evidence of respiratory insufficiency requiring a tracheostomy tube without current need for assisted ventilation.
. Patient will be continuously monitored with telemetry.
. Patient satisfies criteria for the decannulation protocol and agrees to use the Passy Muir Valve during sleep.
. Patient is able to follow directions following speech/language/cognitive evaluation or screening completed by the Speech-Language Pathologist and physician assessment.
. Patient is at least 18 years old.
. An informed consent is signed by patient or Power of Attorney (POA).
. Patient is able to tolerate the PMV during the day for a minimum of 6 continuous hours
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart Rate
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
2
Systolic Blood Pressure
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
3
Diastolic Blood Pressure
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
4
Body Temperature
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
5
O2
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
6
ETCO2
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
7
Respiratory Rate
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00