NCT05357222

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress87%
Nov 2021Dec 2026

First Submitted

Initial submission to the registry

May 10, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

May 10, 2021

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    pre-intervention (initial evaluation)

  • 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).

    8 weeks post intervention

  • 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).

    3 months following intervention

Secondary Outcomes (6)

  • Electroglottography (EGG)

    pre-intervention

  • Electroglottography (EGG)

    8 weeks post intervention

  • Electroglottography (EGG)

    3 months following treatment.

  • Acoustic measurement

    pre-intervention

  • Acoustic measurement

    8 weeks post intervention

  • +1 more secondary outcomes

Study Arms (1)

Straw Phonation

EXPERIMENTAL

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.

Behavioral: Straw phontion

Interventions

Straw phontionBEHAVIORAL

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.

Also known as: Semi-occluded vocal tract exercises, flow resistant tube
Straw Phonation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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).

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

Voice DisordersHoarseness

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, Respiratory

Study Officials

  • Lynn Maxfield, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 2, 2022

Study Start

November 16, 2021

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations