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Mitigation of Acute Voice Changes Follwing Rigorous Voice UsePVUNCT07800702

Effect of Fish Oil Supplementation on the Voice of Female Professional Voice Users (PVU)

A study testing Omega-3 Polyunsaturated Fatty Acids in people with Mitigation of Acute Voice Changes Follwing Rigorous Voice Use, run by Baylor University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

The design of the study allows us to test if there are differences in a battery of voice assessments (Aim 1) and biomarkers from vocal fold secretions (Aim 2) over time (within-subjects factor with 6 levels: 3 pre-intervention and 3 post-intervention) secondary to intervention with an omega-3 polyunsaturated fatty… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Omega-3 Polyunsaturated Fatty Acids
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to Jun 2029
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1) cis-gender female; 2) willingness to be assigned to either the supplement group or placebo group; 3) over the age of the 18 and pre-menopausal; 4) consider themselves a professional voice user, someone who uses their voice to do their job; 5) self-report that their voice gets tired frequently; and 6) have a patent nasal cavity -

Who cannot join

  • 1) have a history of or present diagnosed voice disorder; 2) diagnosed reflux; 3) have a history of or present inflammatory disease; 4) are pregnant; 5) are a vegan; 6) are a smoker or tobacco user; 7) are allergic to fish or shellfish; 8) have been taking a daily omega-3 PUFA supplement in the past 3 months; 9) take a regular anti-inflammatory drug or supplement; 10) have a heightened gag reflex; 11) are unable to pass a hearing screening; 12) are concurrently enrolled in voice therapy or are receiving treatment from an ear, nose, and throat doctor for a laryngeal problem.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

LesLee Funderburk, PhD contact

254-710-7318

leslee_funderburk@baylor.edu

Brittany Perrine, PhD contact

254-710-2587

United States1 site
  • Baylor University

    Waco, Texas, 76798

    April Swindell, 254-710-6812, april_swindell@baylor.edu

Other trials in United States

About this study

Official title: The Effect of Fish Oil Supplementation on the Voice of Female Professional Voice Users

The design of the study allows us to test if there are differences in a battery of voice assessments (Aim 1) and biomarkers from vocal fold secretions (Aim 2) over time (within-subjects factor with 6 levels: 3 pre-intervention and 3 post-intervention) secondary to intervention with an omega-3 polyunsaturated fatty acid or a placebo (between-subjects factor with 2 levels).

Cis-gender females (N = 68) over the age of 18 and pre-menopausal from the McLennan County, TX area will serve as participants in this study. This sample size is the minimum needed to show effect for one voice outcome measures, phonation threshold pressure, accounting for a 20% attrition rate. All human subject research will be performed on Baylor University's campus.

Read the detailed description

Estimates of the prevalence of voice problems range from 1.7-7.6% of the U.S. population based on insurance claims and self-reports, respectively. Many of these voice problems originate from phonotraumatic behaviors such as talking too much, too loudly, or in a way that is inefficient. These phonotraumatic behaviors may result in mechanical disruption to the epithelial tissue, the extracellular matrix of the vocal folds, and the basement membrane zone. In some cases there is capillary damage which can lead to the development of a hemorrhage and polyp formation. What follows is 1) an inflammatory response; 2) the extracellular matrix receiving signals to begin tissue repair; and 3) restoration of the epithelial barrier and tissue remodeling. Even without visible tissue damage the vocal folds may still be participating in the repair process to maintain homeostasis, which is the end goal of an acute inflammatory response. While the acute inflammatory response is generally self-limited, there can be a negative impact on vocal production during this time leading people to seek out anti-inflammatory solutions. This project will test the ability of a natural, accessible, and novel approach using supplementation with omega-3 polyunsaturated fatty acids, to mitigate acute vocal fold inflammation and the resulting voice production changes following extreme voice use.

This research will be carried out by the PI, the project team, and a group of undergraduate and graduate students in multiple disciplines across campus (e.g., speech-language pathology, vocal performance, and physiology), allowing the students to have exposure to each step of the research process. The study is a 10-week randomized, double-blind placebo-controlled trial to determine if supplementation using omega-3 PUFA will improve vocal production measures (Aim 1) and reduce inflammatory biomarkers while increasing anti-inflammatory biomarkers (Aim 2) after a vocal loading task. The overall study design (Figure 4) will provide data to be analyzed for both specific aims.

There will be 68 cis-gender females recruited in total. Only females will be used in this stage of the study because of the increased risk of voice disorders in females compared to males.9 Potential participants will be screened and must meet the following inclusionary criteria: 1) willingness to be assigned to either the Figure 4. Study Design of a 10-week randomized, double-blind supplement group or placebo group; 2) over the age of 18; 3) pre-menopausal; 4) consider themselves a professional voice user (PVU) (see below for PVU definition); 5) self-report that their voice gets tired frequently, confirmed by abnormal scores on the first two parts of the Vocal Fatigue Index (Part 1: tiredness of voice and avoidance of voice use; Part 2: physical discomfort); and 6) have a patent nasal cavity. Exclusionary criteria will include: 1) a history of or present self-reported diagnosed voice disorder; 2) diagnosed reflux; 3) a history of or present inflammatory disease; 4) being a vegan; 5) being a smoker; 6) allergies to fish or shellfish; 7) a history of taking a daily omega-3 PUFA supplement in the past 3 months; 8) currently taking a regular anti-inflammatory drug or supplement; 9) a heightened gag reflex; 10) unable to pass a hearing screening; and 11) being concurrently enrolled in voice therapy or receiving treatment from an ear, nose, and throat doctor for a laryngeal problem. If, upon the initial laryngeal examination, the participant presents an abnormal laryngeal exam, as judged by the ENT, they will be removed from the study. Study activities will be scheduled outside of the 7 days prior to the start of their menses.

Professional Voice User. A professional voice user (PVU) is someone who needs their voice to be consistent and appealing to do their job. This could include people such as a salesperson, clerical worker, teacher, receptionist, lawyer or judge, clergy, psychologist, counselor, telephone operator, interviewer or recruiter, public relations specialist, speech-language pathologist, actor or director, broadcaster, or singer. For the purposes of this study, a PVU will be defined as someone who falls into Koufman and Isaccson levels I (elite vocal performers), II (professional voice users), or III (nonvocal professionals). Participants will be asked the following questions to determine if they are a professional voice user: 1) Would your voice not working or sounding like it normally does prevent you from performing your job adequately?; and 2) What percentage of the workday do you need your voice to sound like it normally does to adequately perform your job?. Individuals who answer "yes" to the first question and who indicate they need their voice to sound like it normally does more than 75% of the day will be classified as a professional voice user.

Being tested
Omega-3 Polyunsaturated Fatty Acids
Keywords
Omega-3 fatty acid, supplementation, professional voice users, intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 Polyunsaturated Fatty AcidsDietary supplement

    RCT, double blind study using 3.0 grams of omega-3 PUFAs/day (Nordic Naturals®) or 3.0 grams of placebo/day (safflower oil, NOW®) for 10 weeks

Study groups in NCT07800702
Study groupRoleWhat they receive
Omega-3 polyunsaturated fatty acidExperimental3.0 grams of omega-3 PUFAs/day (Nordic Naturals®) for 10 weeks
Receives: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids
PlaceboPlacebo comparator3.0 grams of placebo/day (safflower oil, NOW®) for 10 weeks
Receives: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vocal aerodynamic assessment

    A vocal aerodynamic assessment to measure phonation threshold pressure (PTP). Recordings will be made in a double-walled sound attenuating both while the participant is standing. The participant will place a mask system over their face covering the mouth and nose with a small tube that goes between the lips. Participants are able to comfortably breath and speak while wearing the mask and can remove it as they need. Participants will repeat the syllables /pa/ seven times on one breath as softly, smoothly, and evenly as they are able.

    Measured: 10 weeks, to include baseline and end of study

  2. phonation threshold pressure

    A vocal aerodynamic assessment to measure phonation threshold pressure (PTP). Recordings will be made in a double-walled sound attenuating both while the participant is standing. The participant will place a mask system over their face covering the mouth and nose with a small tube that goes between the lips. Participants are able to comfortably breath and speak while wearing the mask and can remove it as they need. Participants will repeat the syllables /pa/ seven times on one breath as softly, smoothly, and evenly as they are able.

    Measured: Initial outcome measure will be assessed at baseline, after that baseline assessment, the measure will be collected every 2 weeks until final end of study assessment

Secondary outcomes (1)
  1. Self-administered vocal ratings

    Three self-ratings of voice production using the Self-Administered Vocal Ratings

    Measured: Initial measure taken at baseline, then 5 weeks after baseline assessment then the last one taken 10 weeks after baseline assessment (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completionMar 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07800702
Sponsor's protocol ID
1921652-10
Other IDs
1R15DC021053-01A1
Acronym
PVU
Status last verified
Aug 2026
First submitted
7 May 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perrine BL, Monzon K, Weber LM, Sturdivant RX, Funderburk LK. The Impact of Omega-3 Polyunsaturated Fatty Acid Supplementation on Singing Training in Vocal Performers: A Non-Randomized Double-Blind Placebo-Controlled Study. Folia Phoniatr Logop. 2024;76(4):352-365. doi: 10.1159/000534769. Epub 2023 Oct 30.

    PubMed 37903469
  • Perrine BL, Monzon K, Weber LM, Funderburk LK. The Impact of Fish Oil Supplementation on Self-Perception of the Voice in Vocal Performers: A Randomized, Single-Blind, Placebo-Controlled Study. J Speech Lang Hear Res. 2021 Dec 13;64(12):4784-4790. doi: 10.1044/2021_JSLHR-21-00295. Epub 2021 Oct 27.

    PubMed 34705542
  • Roy N, Merrill RM, Thibeault S, Gray SD, Smith EM. Voice disorders in teachers and the general population: effects on work performance, attendance, and future career choices. J Speech Lang Hear Res. 2004 Jun;47(3):542-51. doi: 10.1044/1092-4388(2004/042).

    PubMed 15212567
  • Roy N, Merrill RM, Gray SD, Smith EM. Voice disorders in the general population: prevalence, risk factors, and occupational impact. Laryngoscope. 2005 Nov;115(11):1988-95. doi: 10.1097/01.mlg.0000179174.32345.41.

    PubMed 16319611
  • Cohen SM, Kim J, Roy N, Asche C, Courey M. Direct health care costs of laryngeal diseases and disorders. Laryngoscope. 2012 Jul;122(7):1582-8. doi: 10.1002/lary.23189. Epub 2012 Apr 27.

    PubMed 22544473
  • Titze IR, Lemke J, Montequin D. Populations in the U.S. workforce who rely on voice as a primary tool of trade: a preliminary report. J Voice. 1997 Sep;11(3):254-9. doi: 10.1016/s0892-1997(97)80002-1.

    PubMed 9297668
  • Perrine BL, Knepler K, Hooper M. Vocal Hygiene Habits in College Students With and Without Self-Reported Symptoms of a Voice Problem. J Voice. 2026 Jul;40(4):1241.e9-1241.e21. doi: 10.1016/j.jvoice.2024.03.004. Epub 2024 Mar 28.

    PubMed 38553318
  • Wingate JM, Brown WS, Shrivastav R, Davenport P, Sapienza CM. Treatment outcomes for professional voice users. J Voice. 2007 Jul;21(4):433-49. doi: 10.1016/j.jvoice.2006.01.001. Epub 2006 Apr 3.

    PubMed 16581229
  • Vilkman E. Voice problems at work: A challenge for occupational safety and health arrangement. Folia Phoniatr Logop. 2000 Jan-Jun;52(1-3):120-5. doi: 10.1159/000021519.

    PubMed 10474011

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