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Straw Phonation Exercise Program for Pitch Extension (SOVT)

Primary Purpose

Voice Fatigue, Voice Disorders, Voice Hoarseness

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Straw phontion
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Voice Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must be 18 years or older
  • no current voice disorder
  • no history of performance or professional vocal training

Exclusion Criteria:

  • history of head/neck cancer, laryngeal surgery, current voice disorder requiring medical management
  • cognitive limitations that would prevent them from successfully and safely participating in the study.
  • history of gastrointestinal disease or surgery w
  • no known neurological or structural abnormalities of vocal folds
  • previous laryngeal surgeries;
  • allergies to local anesthetics (used to suppress a sensitive gag reflex during laryngeal endoscopic examination);
  • cardiac abnormalities;
  • recent history of smoking (must be completely smoke-free for six months prior to study commencement because of the effect of smoking on the voice and laryngopharyngeal reflux severity).

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Straw Phonation

Arm Description

Participants will undergo one session of voice habilitation via a straw phonation exercise protocol. This protocol has been extensively studied and validated in the largest randomized clinical trial in voice therapy by our team.

Outcomes

Primary Outcome Measures

Voice Range Profile (VRP)
a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud).
Voice Range Profile (VRP)
a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud).
Voice Range Profile (VRP)
a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud).

Secondary Outcome Measures

Electroglottography (EGG)
Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured.
Electroglottography (EGG)
Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured.
Electroglottography (EGG)
Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured.
Acoustic measurement
An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope.
Acoustic measurement
An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope.
Acoustic measurement
An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope.

Full Information

First Posted
May 10, 2021
Last Updated
November 7, 2022
Sponsor
University of Utah
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05357222
Brief Title
Straw Phonation Exercise Program for Pitch Extension
Acronym
SOVT
Official Title
Impact of Vocal Fold Stretching Exercise on Pitch Range and Phonation Stability
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Recruitment has been halted pending a new IRB approval. An annual continuing review deadline was missed, necessitating a new application.
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the change in fundamental frequency range and vocal fold stability achievable with vocal fold stretching exercise in human populations with high and low vocal activity
Detailed Description
The vocal ligament is part of the layered structure of the vocal fold. It is a thin band of tissue near the superior medial edge of the vocal fold. The cord-like appearance of the ligament gave rise to the traditional term "vocal cord". The ligament connects the arytenoid cartilage (lower broad dark region) to the anterior portion of the thyroid cartilage (upper dark region). The slightly thickened endpoints are known as the anterior and posterior macula flava. In the medial-lateral direction, the vocal ligament comprises the intermediate and deep layer of the lamina propria. The physiological functions of the vocal ligament are not fully understood. One function is to limit mechanical strain (elongation), a general function of most ligaments in the body. A second function may be to produce a firm closure of the glottis by forming a straight edge along the membranous (vibrating) portion of the vocal fold. A strong ligament that can be tensed with exercise is likely to help straighten the edge of the folds. Vocal fold bowing, for example, is a pathological condition often associated with advanced age, but it can also occur in young adults who press their arytenoid cartilages together excessively in speech. Atrophy of the thyroarytenoid muscle, which lies lateral to the ligament, causes the middle of the membranous vocal fold to be retracted from the midline of the glottis. The result is a weak voice because airflow cannot be suddenly shut off for efficient acoustic excitation of the vocal tract. For self-sustained vocal fold vibration, the superficial layer must be very pliable and deformable for mucosal surface-wave motion. The role of the ligament is then to stabilize the vertical motion when large pressures are applied to vocal fold surfaces. The most important known function of the ligament, however, is to widen the fundamental frequency range. The stiffer the ligament, the greater the likelihood that several octaves of fo range can be achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Fatigue, Voice Disorders, Voice Hoarseness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be grouped based on their daily vocal usage (i.e. vocal user (4+ hours of speaking per day) or low vocal user (less than 4 hours per day). Both groups will be given a series of vocal stretching exercises that will be completed through a 2mm diameter straw.
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Straw Phonation
Arm Type
Experimental
Arm Description
Participants will undergo one session of voice habilitation via a straw phonation exercise protocol. This protocol has been extensively studied and validated in the largest randomized clinical trial in voice therapy by our team.
Intervention Type
Behavioral
Intervention Name(s)
Straw phontion
Other Intervention Name(s)
Semi-occluded vocal tract exercises, flow resistant tube
Intervention Description
Pitch Glides: (1 minute) Vocalize through the straw starting from as low as possible to as high as possible. As the participant you will want to get as much as your vocal range as possible. But, don't let the voice get growly at the bottom or press it into a painful range at the top. 2. Accents: (1 minute) Vocalize progressive little hills or accents. It sounds like a revving engine of the car. 3. Song: (1 minute) Pick a favorite song and vocalize it through the straw. Examples: National Anthem, Happy Birthday, Mary had a Little Lamb. These are great songs because they have a range of pitches and one can build some accents in, as well. 4. Reading passage: (1 minute) Vocalize a reading passage through the straw. Be as dramatic as possible, using a lot of inflection.
Primary Outcome Measure Information:
Title
Voice Range Profile (VRP)
Description
a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud).
Time Frame
pre-intervention (initial evaluation)
Title
Voice Range Profile (VRP)
Description
a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud).
Time Frame
8 weeks post intervention
Title
Voice Range Profile (VRP)
Description
a thorough voice range profile will be created by testing the participants lowest (minimum) and highest (maximum) achievable pitches across a spectrum of vocal intensities (soft, medium and loud).
Time Frame
3 months following intervention
Secondary Outcome Measure Information:
Title
Electroglottography (EGG)
Description
Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured.
Time Frame
pre-intervention
Title
Electroglottography (EGG)
Description
Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured.
Time Frame
8 weeks post intervention
Title
Electroglottography (EGG)
Description
Electroglottograph, or EGG, is a device used for the noninvasive measurement of the degree of contact between the vibrating vocal folds during voice production. Electrodes are applied on the surface of the neck so that the EGG records variations in the transverse electrical impedance of the larynx can be measured.
Time Frame
3 months following treatment.
Title
Acoustic measurement
Description
An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope.
Time Frame
pre-intervention
Title
Acoustic measurement
Description
An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope.
Time Frame
8 weeks post intervention
Title
Acoustic measurement
Description
An audio recording of each participant will be obtained. The participant will sustain the "ah" and "ee" vowel three times for the maximum amount of time they are able. They will then read the CAPE-V (Zraick et al., 2011), rainbow passage (Fairbanks, 1960), and describe the cookie theft picture (Borod et al., Boston Diagnostic Aphasia Examination 1980). The samples will then be analyzed using Phonanium, an automated acoustic analysis software. Acoustics will include fundamental frequency, fundamental frequency standard deviation, relative sound pressure level (SPL), SPL standard deviation, cepstral peak prominence smooth (CPPS), harmonic to noise ratio, and noise to harmonic ratio, acoustic voice quality index (AVQI), and spectral slope.
Time Frame
3 months following treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must be 18 years or older no current voice disorder no history of performance or professional vocal training Exclusion Criteria: history of head/neck cancer, laryngeal surgery, current voice disorder requiring medical management cognitive limitations that would prevent them from successfully and safely participating in the study. history of gastrointestinal disease or surgery w no known neurological or structural abnormalities of vocal folds previous laryngeal surgeries; allergies to local anesthetics (used to suppress a sensitive gag reflex during laryngeal endoscopic examination); cardiac abnormalities; recent history of smoking (must be completely smoke-free for six months prior to study commencement because of the effect of smoking on the voice and laryngopharyngeal reflux severity).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Maxfield, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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