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

Vocal Restoration Programs After Acute Vocal Exertion

The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. This study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. The investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Vocal rest and Controlled Phonation

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Purdue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• within age range

Exclusion Criteria:

• Voice Disorders
• Strong gag reflex
• Craniofacial disorders
• Cognitive Impairments
• Head and Neck Cancer
• Hearing Difficulties
• Dentition problems that prevent an oral scope being placed in mouth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Adults; Participants will complete vocal rest and controlled phonation	Behavioral: Vocal rest and Controlled Phonation; Voice rest and semi occluded vocal tract voice exercises
Experimental: Healthy Adults reporting Vocal Fatigue; Participants will complete vocal rest and controlled phonation	Behavioral: Vocal rest and Controlled Phonation; Voice rest and semi occluded vocal tract voice exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phonation Threshold Pressure	Minimum air pressure required to initiate and sustain vocal fold oscillation	2.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Volume Excursion	The difference between lung volume initiation and termination on connected speech	2.5 hours

Collaborators and Investigators

• Sponsor: Purdue University
• Investigators: Principal Investigator: Preeti Sivasankar, Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Vocal restoration programs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No