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.
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
- Conditions the study is for
- Mitigation of Acute Voice Changes Follwing Rigorous Voice Use
- 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.
Brittany Perrine, PhD contact
United States1 site
Baylor University
Waco, Texas, 76798
April Swindell, 254-710-6812, april_swindell@baylor.edu
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 group | Role | What they receive |
|---|---|---|
| Omega-3 polyunsaturated fatty acid | Experimental | 3.0 grams of omega-3 PUFAs/day (Nordic Naturals®) for 10 weeks Receives: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids |
| Placebo | Placebo comparator | 3.0 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.
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
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)
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.
- First posted2 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mitigation of Acute Voice Changes Follwing Rigorous Voice UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
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 37903469Perrine 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 34705542Roy 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 15212567Roy 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 16319611Cohen 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 22544473Titze 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 9297668Perrine 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 38553318Wingate 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 16581229Vilkman 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