NCT04912544

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

April 28, 2021

Last Update Submit

July 28, 2022

Conditions

Noninvasive VentilationSpeech Intelligibility

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    Immediately after speaking tasks are complete

  • Rating of speech comprehensibility

    Immediately after speaking tasks are complete

  • Rating of how natural the speech sound quality is

    Immediately after speaking tasks are complete

Study Arms (2)

Arm 1

EXPERIMENTAL

Patient talking with microphone first turned on and then off

Device: Noninvasive Ventilation Mask Microphone

Arm 2

EXPERIMENTAL

Patient talking with microphone first turned off and then on

Device: Noninvasive Ventilation Mask Microphone

Interventions

Noninvasive Ventilation Mask MicrophoneDEVICE

Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study

Arm 1Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Speech Intelligibility

Condition Hierarchy (Ancestors)

SpeechVerbal BehaviorCommunicationBehavior

Study Officials

  • Lara Brewer, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2021

First Posted

June 3, 2021

Study Start

October 11, 2021

Primary Completion

April 15, 2022

Study Completion

May 9, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)