Trial Outcomes & Findings for Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults (NCT NCT03762993)

NCT ID: NCT03762993

Last Updated: 2021-08-05

Results Overview

Minimum air pressure required to initiate and sustain vocal fold oscillation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 2.5 hours
• Results posted on: 2021-08-05

Participant Flow

Of 37 enrolled participants, 31 were assigned to study groups based on self-reported vocal fatigue level.

Participant milestones

Measure	Healthy Adults Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises	Healthy Adults Reporting Vocal Fatigue Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises
Overall Study STARTED	21	10
Overall Study COMPLETED	21	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults

Baseline characteristics by cohort

Measure	Healthy Adults n=21 Participants Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises	Healthy Adults Reporting Vocal Fatigue n=10 Participants Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	6 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	9 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	10 participants n=7 Participants	31 participants n=5 Participants
Vocal Fatigue Index Vocal Fatigue Index Part 1	4 units on a scale n=5 Participants	24 units on a scale n=7 Participants	4 units on a scale n=5 Participants
Vocal Fatigue Index Vocal Fatigue Index Part 2	0 units on a scale n=5 Participants	3.5 units on a scale n=7 Participants	2 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 2.5 hours

Minimum air pressure required to initiate and sustain vocal fold oscillation

Outcome measures

Measure	Healthy Adults n=21 Participants Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises	Healthy Adults Reporting Vocal Fatigue n=10 Participants Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises
Phonation Threshold Pressure Pre-Exertion	5.41 cmH20 Standard Deviation 1.26	5.08 cmH20 Standard Deviation 1.59
Phonation Threshold Pressure Post-Exertion	6.39 cmH20 Standard Deviation 1.8	6.33 cmH20 Standard Deviation 1.4
Phonation Threshold Pressure Post Restoration Strategy	5.63 cmH20 Standard Deviation 1.32	5.61 cmH20 Standard Deviation 1.59

SECONDARY outcome

Timeframe: 2.5 hours

The difference between lung volume initiation and termination on connected speech

Outcome measures

Measure	Healthy Adults n=21 Participants Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises	Healthy Adults Reporting Vocal Fatigue n=10 Participants Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises
Lung Volume Excursion Baseline	13.5 % Vital Capacity Standard Deviation 7.2	14.5 % Vital Capacity Standard Deviation 6.4
Lung Volume Excursion Post Exertion	21.6 % Vital Capacity Standard Deviation 10.6	12.9 % Vital Capacity Standard Deviation 6.5
Lung Volume Excursion Post Restoration Strategy	18.7 % Vital Capacity Standard Deviation 11.5	18.4 % Vital Capacity Standard Deviation 7.15

Adverse Events

Healthy Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Adults Reporting Vocal Fatigue

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Preeti Sivasankar

Purdue University

Phone: 765-494-3788

Email: preeti@purdue.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place