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

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ClinicalTrials.gov Identifier: NCT03762993
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Preeti M. Sivasankar, Purdue University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Vocal rest and Controlled Phonation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Within Subject Design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vocal Restoration Programs After Acute Vocal Exertion
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

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




Primary Outcome Measures :
  1. Phonation Threshold Pressure [ Time Frame: 2.5 hours ]

Secondary Outcome Measures :
  1. Lung Volume Initiation and Termination [ Time Frame: 2.5 hours ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762993


Contacts
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Contact: Preeti Sivasankar 765-496-6628 preeti@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47906
Contact: Preeti Sivasankar    765-496-6628    preeti@purdue.edu   
Sponsors and Collaborators
Purdue University
Investigators
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Principal Investigator: Preeti Sivasankar Purdue University

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Responsible Party: Preeti M. Sivasankar, Professor, Purdue University
ClinicalTrials.gov Identifier: NCT03762993     History of Changes
Other Study ID Numbers: Vocal restoration programs
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No