TracheostomyNCT06229639

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

A study testing Passy Muir Valve and Tracheostomy Plug in people with Tracheostomy, run by Gaylord Hospital, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Tracheostomy
What is being tested?: Passy Muir Valve and Tracheostomy Plug
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: Jan 2016to Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
Patient has a maximum size #6 Shiley cuffless tracheostomy tube or equivalent.

Who cannot join

Patient identified at time of admission as requiring invasive long-term assisted ventilation.
Patient with documented or suspected upper airway obstruction and/or surgery or permanent tracheostomy tube.
Patient is quadriplegic (due to the inability for a quadriplegic patient to manually self-remove the valve in case of emergency).
Patient or POA failed to sign consent.
Pt has a severe cognitive impairment as determined by a formal cognitive-linguistic evaluation by a licensed Speech Language Pathologist.
Patient unable to meet criteria for decannulation protocol or has failed decannulation protocol within last two weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gaylord Hospital
Wallingford, Connecticut, 06492

Other trials in United States

About this study

Official title: Assessing the Safety of the Nocturnal Passy Muir Valve and Its Impact on Sleep Quality in 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. 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.

Read the 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
Being tested: Passy Muir Valve, Tracheostomy Plug
Keywords: Tracheostomy, Speaking Valve, Sleep Quality, LTACH, Passy-Muir Valve, Respiratory Care
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Passy Muir ValveDevice
Tracheostomy PlugDevice

Study groups in NCT06229639
Study group	Role	What they receive
Tracheostomy Plug	Active comparator	Patients receive tracheostomy plug during night 2. Receives: Device: Tracheostomy Plug
Passy-Muir Valve	Experimental	Patients receive Passy-Muir Valve during night 1. Receives: Device: Passy Muir Valve

What is being measured

The primary outcome is the main question the study is designed to answer.

Heart Rate
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.
Measured: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Systolic Blood Pressure
Measures the pressure in your arteries when your heart beats (mmHg). 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.
Measured: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Diastolic Blood Pressure
Measures the pressure in your arteries when your heart rests between beats (mmHg). 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.
Measured: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Body Temperature
Measures the normal body temperature of participants (°F). 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.
Measured: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
O2
Oxygen saturation measures the percentage of oxyhemoglobin in the blood (%). 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.
Measured: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
ETCO2
The level of carbon dioxide that is released at the end of an exhaled breath (mm Hg). 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.
Measured: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Respiratory Rate
Measures the breathing rate by number of breaths 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.
Measured: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00

Secondary outcomes (6)

pH
The amount of pH in the blood is measured by the arterial blood gas measurements.
Measured: Morning after night 1 and morning after night 2
PCO2
The amount of carbon dioxide in the blood in the arterial blood gas measurements (mm Hg).
Measured: Morning after night 1 and morning after night 2
PO2
The amount of oxygen in the blood by the arterial blood gas measurements (mm Hg).
Measured: Morning after night 1 and morning after night 2
Bicarbonate
The amount of bicarbonate in the blood by the arterial blood gas measurements (mmol/L).
Measured: Morning after night 1 and morning after night 2
Sleep Quality
This is measured by the Richards-Campbell Sleep Questionnaire, which is recorded on a 0-100 nm (minimum-maximum values) visual scale with higher scores indicating better sleep levels than lower scores.
Measured: Morning after night 1 and morning after night 2
Richard Campbell Sleep Questionnaire
The Richards-Campbell Sleep Questionnaire (RCSQ) is a six-question self-report questionnaire used to assess ICU patients' sleep quality. These six questions assess the domains of sleep depth, sleep latency, awakenings, ability to return to sleep, overall sleep quality, and overnight noise level. The responses were recorded on a 0-100 mm visual analog scale, with higher scores indicating better sleep levels than lower scores. The mean score represents the general perception of sleep quality.
Measured: Morning after night 1 and morning after night 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Feb 2018

First posted29 Jan 2024
Study startJan 2016
Primary completionJan 2018
Study completionFeb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for TracheostomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06229639
Sponsor's protocol ID: 201512TAN
Status last verified: Mar 2026
First submitted: 21 Dec 2023
Last updated: 11 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
PubMed 20667153
Lian S, Teng L, Mao Z, Jiang H. Clinical utility and future direction of speaking valve: A review. Front Surg. 2022 Sep 8;9:913147. doi: 10.3389/fsurg.2022.913147. eCollection 2022.
PubMed 36157432
Liney T, Dawson R, Seth R, et al. Anxiety levels amongst patients with tracheostomies. British Journal of Anaesthesia. 2019;123(4):e504-e505. doi:10.1016/j.bja.2019.04.027
O'Connor LR, Morris NR, Paratz J. Physiological and clinical outcomes associated with use of one-way speaking valves on tracheostomised patients: A systematic review. Heart Lung. 2019 Jul-Aug;48(4):356-364. doi: 10.1016/j.hrtlng.2018.11.006. Epub 2018 Dec 17.
PubMed 30573194
Passy V, Baydur A, Prentice W, Darnell-Neal R. Passy-Muir tracheostomy speaking valve on ventilator-dependent patients. Laryngoscope. 1993 Jun;103(6):653-8. doi: 10.1288/00005537-199306000-00013.
PubMed 8502098
Winters B, Serpas D, Fullmer N, Hughes K, Kincaid J, Rosario ER, Schnakers C. Sleep Quality Should Be Assessed in Inpatient Rehabilitation Settings: A Preliminary Study. Brain Sci. 2023 Apr 25;13(5):718. doi: 10.3390/brainsci13050718.
PubMed 37239190
DuBose JR, Hadi K. Improving inpatient environments to support patient sleep. Int J Qual Health Care. 2016 Oct;28(5):540-553. doi: 10.1093/intqhc/mzw079. Epub 2016 Aug 10.
PubMed 27512130
Martin JL, Fiorentino L, Jouldjian S, Josephson KR, Alessi CA. Sleep quality in residents of assisted living facilities: effect on quality of life, functional status, and depression. J Am Geriatr Soc. 2010 May;58(5):829-36. doi: 10.1111/j.1532-5415.2010.02815.x.
PubMed 20722819
Shuman AG, Duffy SA, Ronis DL, Garetz SL, McLean SA, Fowler KE, Terrell JE. Predictors of poor sleep quality among head and neck cancer patients. Laryngoscope. 2010 Jun;120(6):1166-72. doi: 10.1002/lary.20924.
PubMed 20513034
510(k) Premarket Notification. U.S. Food and Drug Administration. Accessed June 23, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K962714
Barraza GY, Fernandez C, Halaby C, Ambrosio S, Simpser EF, Pirzada MB, Islam S. The safety of tracheostomy speaking valve use during sleep in children: a pilot study. Am J Otolaryngol. 2014 Sep-Oct;35(5):636-40. doi: 10.1016/j.amjoto.2014.04.011. Epub 2014 May 4.
PubMed 24888795
Gross RD, Atwood C. R168: Safety of Tracheostomy Speaking Valve Use during Sleep. Otolaryngol Head Neck Surg. 2007;137(2_suppl):P209-P209. doi:10.1016/j.otohns.2007.06.505
Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
PubMed 11227580
Silveira AR, Soki MN, Chone CT, Tah Y Ng R, Carvalho EG, Crespo AN. Brazilian tracheotomy speech valve: diaphragm pressure standardization. Braz J Otorhinolaryngol. 2009 Jan-Feb;75(1):107-10. doi: 10.1016/s1808-8694(15)30840-5.
PubMed 19488569

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Tracheostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Safety of the Nocturnal Passy Muir Valve and Its Impact on Sleep Quality in an LTACH Setting
ClinicalTrials.gov ID: NCT06229639
Acronym / sponsor ID: 201512TAN
Conditions: Tracheostomy
Keywords: Tracheostomy, Speaking Valve, Sleep Quality, LTACH, Passy-Muir Valve, Respiratory Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Gaylord Hospital, IncUniversity, hospital or other
Study start: Jan 2016 (actual)
Primary completion: Jan 2018 (actual)
Study completion: Feb 2018 (actual)
First posted: 29 Jan 2024 (actual)
Results: Posted 11 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tracheostomy Plug	Active comparator	Device: Tracheostomy PlugPatients receive tracheostomy plug during night 2.
Passy-Muir Valve	Experimental	Device: Passy Muir ValvePatients receive Passy-Muir Valve during night 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (6 listed)

Patient identified at time of admission as requiring invasive long-term assisted ventilation.
Patient with documented or suspected upper airway obstruction and/or surgery or permanent tracheostomy tube.
Patient is quadriplegic (due to the inability for a quadriplegic patient to manually self-remove the valve in case of emergency).
Patient or POA failed to sign consent.
Pt has a severe cognitive impairment as determined by a formal cognitive-linguistic evaluation by a licensed Speech Language Pathologist.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Passy Muir Valve	Device	Passy-Muir Valve
Tracheostomy Plug	Device	Tracheostomy Plug

Primary outcome

Heart Rate
Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
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.
Systolic Blood Pressure
Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Measures the pressure in your arteries when your heart beats (mmHg). 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.
Diastolic Blood Pressure
Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Measures the pressure in your arteries when your heart rests between beats (mmHg). 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.
Body Temperature
Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Measures the normal body temperature of participants (°F). 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.
O2
Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Oxygen saturation measures the percentage of oxyhemoglobin in the blood (%). 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.
ETCO2
Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
The level of carbon dioxide that is released at the end of an exhaled breath (mm Hg). 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.
Respiratory Rate
Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Measures the breathing rate by number of breaths 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.

6 secondary outcomes

pH
Time frame: Morning after night 1 and morning after night 2
PCO2
Time frame: Morning after night 1 and morning after night 2
PO2
Time frame: Morning after night 1 and morning after night 2
Bicarbonate
Time frame: Morning after night 1 and morning after night 2
Sleep Quality
Time frame: Morning after night 1 and morning after night 2
Richard Campbell Sleep Questionnaire
Time frame: Morning after night 1 and morning after night 2

Results and safety

Results posted to the registry on 11 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Passy-Muir Valve First, Then Tracheostomy Plug	30	27

Primary outcome: Heart Rate

Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00. Mean (95% Confidence Interval). Unit: beats per minute

Measure	Passy-Muir Valve n = 26	Tracheostomy Plug n = 26
Value	84.10 (78.54 to 89.67)	84.33 (78.84 to 89.82)

Passy-Muir Valve vs Tracheostomy Plug: p = 0.87, t-test, 2 sided

Primary outcome: Systolic Blood Pressure

Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00. Mean (95% Confidence Interval). Unit: millimeters of mercury

Measure	Passy-Muir Valve n = 26	Tracheostomy Plug n = 26
Value	124.6 (117.4 to 131.8)	127.6 (121.4 to 133.8)

Passy-Muir Valve vs Tracheostomy Plug: p = 0.18, t-test, 2 sided

Primary outcome: Diastolic Blood Pressure

Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00. Mean (95% Confidence Interval). Unit: millimeters of mercury

Measure	Passy-Muir Valve n = 26	Tracheostomy Plug n = 26
Value	70.73 (67.67 to 73.79)	73.46 (70.46 to 76.46)

Passy-Muir Valve vs Tracheostomy Plug: p = 0.02, t-test, 2 sided

Primary outcome: Body Temperature

Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00. Mean (95% Confidence Interval). Unit: degrees Fahrenheit

Measure	Passy-Muir Valve n = 26	Tracheostomy Plug n = 26
Value	98.08 (97.96 to 98.19)	98.05 (97.95 to 98.14)

Passy-Muir Valve vs Tracheostomy Plug: p = 0.64, t-test, 2 sided

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 participants were at risk. The participants were monitored for adverse events over the 2-day study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tracheostomy Plug	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Passy-Muir Valve	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): This study is limited by a small sample size, short duration, lack of randomization, and the high-acuity LTACH patient population, whose comorbidities may affect sleep quality. Since only decannulation candidates were included, findings may not generalize to others or reflect outcomes if PMV use began earlier. Larger, randomized, longer studies comparing early vs. late nighttime PMV use are needed to better assess its impact on sleep and clinical outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20667153Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
Background: PubMed 36157432Lian S, Teng L, Mao Z, Jiang H. Clinical utility and future direction of speaking valve: A review. Front Surg. 2022 Sep 8;9:913147. doi: 10.3389/fsurg.2022.913147. eCollection 2022.
BackgroundLiney T, Dawson R, Seth R, et al. Anxiety levels amongst patients with tracheostomies. British Journal of Anaesthesia. 2019;123(4):e504-e505. doi:10.1016/j.bja.2019.04.027
Background: PubMed 30573194O'Connor LR, Morris NR, Paratz J. Physiological and clinical outcomes associated with use of one-way speaking valves on tracheostomised patients: A systematic review. Heart Lung. 2019 Jul-Aug;48(4):356-364. doi: 10.1016/j.hrtlng.2018.11.006. Epub 2018 Dec 17.
Background: PubMed 8502098Passy V, Baydur A, Prentice W, Darnell-Neal R. Passy-Muir tracheostomy speaking valve on ventilator-dependent patients. Laryngoscope. 1993 Jun;103(6):653-8. doi: 10.1288/00005537-199306000-00013.
Background: PubMed 37239190Winters B, Serpas D, Fullmer N, Hughes K, Kincaid J, Rosario ER, Schnakers C. Sleep Quality Should Be Assessed in Inpatient Rehabilitation Settings: A Preliminary Study. Brain Sci. 2023 Apr 25;13(5):718. doi: 10.3390/brainsci13050718.
Background: PubMed 27512130DuBose JR, Hadi K. Improving inpatient environments to support patient sleep. Int J Qual Health Care. 2016 Oct;28(5):540-553. doi: 10.1093/intqhc/mzw079. Epub 2016 Aug 10.
Background: PubMed 20722819Martin JL, Fiorentino L, Jouldjian S, Josephson KR, Alessi CA. Sleep quality in residents of assisted living facilities: effect on quality of life, functional status, and depression. J Am Geriatr Soc. 2010 May;58(5):829-36. doi: 10.1111/j.1532-5415.2010.02815.x.
Background: PubMed 20513034Shuman AG, Duffy SA, Ronis DL, Garetz SL, McLean SA, Fowler KE, Terrell JE. Predictors of poor sleep quality among head and neck cancer patients. Laryngoscope. 2010 Jun;120(6):1166-72. doi: 10.1002/lary.20924.
Background510(k) Premarket Notification. U.S. Food and Drug Administration. Accessed June 23, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K962714
Background: PubMed 24888795Barraza GY, Fernandez C, Halaby C, Ambrosio S, Simpser EF, Pirzada MB, Islam S. The safety of tracheostomy speaking valve use during sleep in children: a pilot study. Am J Otolaryngol. 2014 Sep-Oct;35(5):636-40. doi: 10.1016/j.amjoto.2014.04.011. Epub 2014 May 4.
BackgroundGross RD, Atwood C. R168: Safety of Tracheostomy Speaking Valve Use during Sleep. Otolaryngol Head Neck Surg. 2007;137(2_suppl):P209-P209. doi:10.1016/j.otohns.2007.06.505
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cheryl Tansley, SLP principal investigator

Gaylord Specialty Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Passy Muir Valve and Tracheostomy Plug in people with Tracheostomy, run by Gaylord Hospital, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate (time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06229639, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.