Noninvasive VentilationNCT04912544
Facilitating Patient Communication During Noninvasive Ventilation
A study testing Noninvasive Ventilation Mask Microphone in people with Noninvasive Ventilation and Speech Intelligibility, run by University of Utah at 1 site in United States.
Trial summary
Assessing speech intelligibility in a pilot study of patients speaking with a mask microphone while being treated with standard of care non-invasive ventilation. This is a feasibility study to test the microphone in a real world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation, Speech Intelligibility
- What is being tested?
- Noninvasive Ventilation Mask Microphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 9 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age greater than or equal to 18 years
- Currently hospitalized
- Awake and able to attempt communication
- Respiratory failure requiring non-invasive ventilatory support
- Positive Inspiratory Pressure (PIP) less than or equal to 20 cm H2O
- Positive End Expiratory Pressure (PEEP) less than or equal to 10 cm H2O
Show all 9Show fewer
- FiO2 less than or equal to 0.60
- Clinical attending physician believes it is safe for the patient to participate
- Able to consent o If patient cannot consent on the basis of difficulty in being heard and asking questions (as in fact may occur with NIV, a key assumption of this study), then assent will be obtained from the patient with informed consent obtained from a legally authorized representative.
Who cannot join
- Tachypnea with RR > 35
- Increase in PIP, PEEP or FiO2 over the last 2 hours
- Known to be delirious (clinically obtained CAM score that is positive)
- Prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Intelligibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation
Assessing speech intelligibility in a pilot study of patients speaking with a mask microphone while being treated with standard of care non-invasive ventilation. This is a feasibility study to test the microphone in a real world setting.
Read the detailed description
We will conduct a prospective feasibility study to evaluate speech intelligibility of 10 patients (target distribution of gender: 5 males, 5 females) undergoing standard of care, clinically indicated non-invasive ventilation. Patients will be their own control with and without the ReddyPort™ microphone using a crossover design, with the sequence of conditions randomized (half of patients start with microphone turned on, half start with the microphone turned off). The patients in this study will all receive standard of care. No medical decisions for a change in care will result from the speech recordings obtained during this feasibility study. The speech recordings will be analyzed off-site using a pool of blinded volunteers. The microphone on and off test conditions will not be used to change outcome of the clinical course of care.
- Conditions
- Noninvasive Ventilation, Speech Intelligibility
- Being tested
- Noninvasive Ventilation Mask Microphone
- Medical subject headings
- Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Ventilation Mask MicrophoneDevice
Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patient talking with microphone first turned on and then off Receives: Device: Noninvasive Ventilation Mask Microphone |
| Arm 2 | Experimental | Patient talking with microphone first turned off and then on Receives: Device: Noninvasive Ventilation Mask Microphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of speech intelligibility
The 1-5 likert scale developed by Yorkston et al will be used to evaluate speech intelligibility of the device (Yorkston, Kathryn M., David R. Beukelman, and Charles Traynor. Assessment of intelligibility of dysarthric speech. Austin, TX: Pro-ed, 1984.Powell TW. A comparison of English reading passages for elicitation of speech samples from clinical populations. Clin Linguist Phon. 2006;20(2-3):91-7)
Measured: Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete.
Secondary outcomes (3)
Rating of microphone likability
Subjects will be asked how well they liked using the microphone on a Likert-type scale of 1-5, from extremely unlikable (1) to extremely likable (5)
Measured: Immediately after speaking tasks are complete
Rating of speech comprehensibility
Subjects will be asked how well they could understand the speech on a Likert-type scale of 1-5, from not at all understandable (1) to fully understandable (5)
Measured: Immediately after speaking tasks are complete
Rating of how natural the speech sound quality is
Subjects will be asked how natural the speech sound quality is on a Likert-type scale of 1-5, from not natural (1) to completely natural (5)
Measured: Immediately after speaking tasks are complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start11 Oct 2021
- Primary completion15 Apr 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentilationStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Axon Medical, Inc., Intermountain Health Care, Inc., National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sarah Ferguson, University of Utah
- Investigators
- Lara Brewer, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912544
- Sponsor's protocol ID
- 00056030
- Other IDs
- 1R43HL147788-01A1
- Status last verified
- Jul 2022
- First submitted
- 28 Apr 2021
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young ED, Ferguson SH, Brewer LM, Schiedermayer BF, Brown SM, Leither LM. Using a novel in-mask non-invasive ventilator microphone to improve talker intelligibility in healthy and hospitalised adults. Int J Speech Lang Pathol. 2024 Dec;26(6):845-860. doi: 10.1080/17549507.2023.2251726. Epub 2023 Oct 13.
PubMed 37837223
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Intelligibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation
- ClinicalTrials.gov ID
- NCT04912544
- Acronym / sponsor ID
- 00056030
- Conditions
- Noninvasive Ventilation, Speech Intelligibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Axon Medical, Inc., Intermountain Health Care, Inc., National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing speech intelligibility in a pilot study of patients speaking with a mask microphone while being treated with standard of care non-invasive ventilation. This is a feasibility study to test the microphone in a real world setting.
Detailed description
We will conduct a prospective feasibility study to evaluate speech intelligibility of 10 patients (target distribution of gender: 5 males, 5 females) undergoing standard of care, clinically indicated non-invasive ventilation. Patients will be their own control with and without the ReddyPort™ microphone using a crossover design, with the sequence of conditions randomized (half of patients start with microphone turned on, half start with the microphone turned off). The patients in this study will all receive standard of care. No medical decisions for a change in care will result from the speech recordings obtained during this feasibility study. The speech recordings will be analyzed off-site using a pool of blinded volunteers. The microphone on and off test conditions will not be used to change outcome of the clinical course of care.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Noninvasive Ventilation Mask MicrophonePatient talking with microphone first turned on and then off |
| Arm 2 | Experimental | Device: Noninvasive Ventilation Mask MicrophonePatient talking with microphone first turned off and then on |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than or equal to 18 years
- Currently hospitalized
- Awake and able to attempt communication
- Respiratory failure requiring non-invasive ventilatory support
- Positive Inspiratory Pressure (PIP) less than or equal to 20 cm H2O
Key exclusion criteria (4 listed)
- Tachypnea with RR > 35
- Increase in PIP, PEEP or FiO2 over the last 2 hours
- Known to be delirious (clinically obtained CAM score that is positive)
- Prisoner
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 |
|---|---|---|
| Noninvasive Ventilation Mask MicrophoneNoninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study | Device | Arm 1, Arm 2 |
Primary outcome
Rating of speech intelligibility
Time frame: Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete.
The 1-5 likert scale developed by Yorkston et al will be used to evaluate speech intelligibility of the device (Yorkston, Kathryn M., David R. Beukelman, and Charles Traynor. Assessment of intelligibility of dysarthric speech. Austin, TX: Pro-ed, 1984.Powell TW. A comparison of English reading passages for elicitation of speech samples from clinical populations. Clin Linguist Phon. 2006;20(2-3):91-7)
3 secondary outcomes
Rating of microphone likability
Time frame: Immediately after speaking tasks are complete
Rating of speech comprehensibility
Time frame: Immediately after speaking tasks are complete
Rating of how natural the speech sound quality is
Time frame: Immediately after speaking tasks are complete
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Derived from this study: PubMed 37837223Young ED, Ferguson SH, Brewer LM, Schiedermayer BF, Brown SM, Leither LM. Using a novel in-mask non-invasive ventilator microphone to improve talker intelligibility in healthy and hospitalised adults. Int J Speech Lang Pathol. 2024 Dec;26(6):845-860. doi: 10.1080/17549507.2023.2251726. Epub 2023 Oct 13.
- 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.
Lara Brewer, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive Ventilation Mask Microphone in people with Noninvasive Ventilation and Speech Intelligibility, run by University of Utah 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 9 inclusion and 4 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 1 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rating of speech intelligibility (time frame: Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete.). 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 NCT04912544, which also lists 1 linked publication.
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 1 Aug 2022.