PresbyphoniaNCT05856916
Creatine Supplementation for Improved Voice Performance in the Elderly
A study testing Creatine monohydrate in people with Presbyphonia, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary objective of this study is to determine if creatine supplementation improves acoustic, auditory perceptual, physiologic, and patient-reported outcome measures in patients over 65 years of age. In the study, 20 participants will be enrolled and randomly assigned to receive either creatine or placebo. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Presbyphonia
- What is being tested?
- Creatine monohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Desiring to participate in voice therapy
Who cannot join
- Lesions or abnormalities of the larynx not attributable to normal aging
- Pre-existing renal disease
- Pre-existing liver disease
- Congestive heart failure
- Blood urea nitrogen (BUN), creatine, alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT) over reference range in the last 6 months
- Concurrent medication associated with reduced renal clearance (e.g. Nonsteroidal Anti-inflammatory Drugs (NSAIDs), metformin)
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- History of prior vocal fold augmentation procedures
- Cognitive disability
- Unwillingness to participate in voice therapy
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine if creatine supplementation improves acoustic, auditory perceptual, physiologic, and patient-reported outcome measures in patients over 65 years of age. In the study, 20 participants will be enrolled and randomly assigned to receive either creatine or placebo.
Read the detailed description
This will be a double-blinded, placebo-controlled interventional trial. Participants will be 65 years or older who present to the NYU voice center for voice complaints and desired voice therapy for improved vocal performance. Upon enrollment, participants will undergo evaluation for measures of vocal function (acoustic and aerodynamic measures of voice production), laryngeal physiology (electroglottography, videostroboscopy), and voice-associated quality of life (voice handicap index 10 , OMNI vocal effort scale, aging voice index). Participants will be randomized to receive either daily oral creatine supplementation or placebo. After 4 weeks, repeat measures will be taken. At this time, participants will initiate a standard-of-care course of voice therapy directed at improved vocal strength and endurance. The duration of therapy will be approximately 6 weeks. Participants will continue creatine supplementation or placebo through the course of therapy and repeat measures will be assessed at the conclusion of voice therapy. This will mark the end of the study period for each subject.
- Conditions
- Presbyphonia
- Being tested
- Creatine monohydrate, Placebo
- Keywords
- creatine, presbyphonia, presbylarynx, vocal atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDietary supplement
Also called Creapure
Creatine monohydrate will be self-administered by an oral route at a dose of 5g/day in powdered form. Administration will begin on Study Day 1 and continue for 10 weeks.
PlaceboDietary supplement
Placebo (in the form of lactose) will be self-administered by an oral route at a dose of 5g/day in powdered form. Administration will begin on Study Day 1 and continue for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Creatine Supplementation | Experimental | Participants randomized to receive creatine. Study participants will be asked to track their daily administration on a log provided by the study team. Receives: Dietary Supplement: Creatine monohydrate |
| Placebo | Placebo comparator | Participants randomized to receive placebo. Study participants will be asked to track their daily administration on a log provided by the study team. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Voice Handicap Index (VHI)-10 Scores
10-item questionnaire assessing a patient's perception of impairment or handicap due to a voice problem. Items are ranked on a scale ranging from 0 to 4, where 0 = Never and 4 = Always. The total score ranges from 0-40; higher scores indicate greater impairment or handicap due to a voice problem.
Measured: Baseline, Week 10
Average Expert Rating of Change in Mucosal Wave
Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in mucosal wave on a relative 3-point scale (1 = worse, 2 = same, 3 = better).
Measured: Week 10
Average Expert Rating of Change in Vocal Fold Atrophy
Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in vocal fold atrophy on a relative 3-point scale (1 = worse, 2 = same, 3 = better).
Measured: Week 10
Average Expert Rating of Change in Glottal Closure
Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in glottal closure on a relative 3-point scale (1 = worse, 2 = same, 3 = better).
Measured: Week 10
Average Phonatory Pressure during Aerodynamic Analysis of Voice
Patients are instructed to produce five productions of /pa/ at their most comfortable pitch and loudness at a rate of approximately 1.5 syllables per second. The middle three productions will be analyzed to determine the average phonatory pressure.
Measured: Up to Week 10
Average Decibel (dB) Output during Aerodynamic Analysis of Voice
Patients are instructed to produce five productions of /pa/ at their most comfortable pitch and loudness at a rate of approximately 1.5 syllables per second. The middle three productions will be analyzed to determine the average dB output.
Measured: Up to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 May 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: Project is on indefinite hold due to a lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyphoniaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Johnson, Principal investigator, Aaron.Johnson@nyulangone.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856916
- Sponsor's protocol ID
- 22-01536
- Status last verified
- Mar 2026
- First submitted
- 4 May 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single institution study and all patient data will be limited to the primary research team
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation for Improved Voice Performance in the Elderly
- ClinicalTrials.gov ID
- NCT05856916
- Acronym / sponsor ID
- 22-01536
- Conditions
- Presbyphonia
- Keywords
- creatine, presbyphonia, presbylarynx, vocal atrophy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Project is on indefinite hold due to a lack of funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine if creatine supplementation improves acoustic, auditory perceptual, physiologic, and patient-reported outcome measures in patients over 65 years of age. In the study, 20 participants will be enrolled and randomly assigned to receive either creatine or placebo.
Detailed description
This will be a double-blinded, placebo-controlled interventional trial. Participants will be 65 years or older who present to the NYU voice center for voice complaints and desired voice therapy for improved vocal performance. Upon enrollment, participants will undergo evaluation for measures of vocal function (acoustic and aerodynamic measures of voice production), laryngeal physiology (electroglottography, videostroboscopy), and voice-associated quality of life (voice handicap index 10 , OMNI vocal effort scale, aging voice index). Participants will be randomized to receive either daily oral creatine supplementation or placebo. After 4 weeks, repeat measures will be taken. At this time, participants will initiate a standard-of-care course of voice therapy directed at improved vocal strength and endurance. The duration of therapy will be approximately 6 weeks. Participants will continue creatine supplementation or placebo through the course of therapy and repeat measures will be assessed at the conclusion of voice therapy. This will mark the end of the study period for each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine Supplementation | Experimental | Dietary Supplement: Creatine monohydrateParticipants randomized to receive creatine. Study participants will be asked to track their daily administration on a log provided by the study team. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants randomized to receive placebo. Study participants will be asked to track their daily administration on a log provided by the study team. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older
- Desiring to participate in voice therapy
Key exclusion criteria (9 listed)
- Lesions or abnormalities of the larynx not attributable to normal aging
- Pre-existing renal disease
- Pre-existing liver disease
- Congestive heart failure
- Blood urea nitrogen (BUN), creatine, alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT) over reference range in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine monohydrateAlso: CreapureCreatine monohydrate will be self-administered by an oral route at a dose of 5g/day in powdered form. Administration will begin on Study Day 1 and continue for 10 weeks. | Dietary supplement | Creatine Supplementation |
| PlaceboPlacebo (in the form of lactose) will be self-administered by an oral route at a dose of 5g/day in powdered form. Administration will begin on Study Day 1 and continue for 10 weeks. | Dietary supplement | Placebo |
Primary outcome
Change from Baseline in Voice Handicap Index (VHI)-10 Scores
Time frame: Baseline, Week 10
10-item questionnaire assessing a patient's perception of impairment or handicap due to a voice problem. Items are ranked on a scale ranging from 0 to 4, where 0 = Never and 4 = Always. The total score ranges from 0-40; higher scores indicate greater impairment or handicap due to a voice problem.
Average Expert Rating of Change in Mucosal Wave
Time frame: Week 10
Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in mucosal wave on a relative 3-point scale (1 = worse, 2 = same, 3 = better).
Average Expert Rating of Change in Vocal Fold Atrophy
Time frame: Week 10
Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in vocal fold atrophy on a relative 3-point scale (1 = worse, 2 = same, 3 = better).
Average Expert Rating of Change in Glottal Closure
Time frame: Week 10
Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in glottal closure on a relative 3-point scale (1 = worse, 2 = same, 3 = better).
Average Phonatory Pressure during Aerodynamic Analysis of Voice
Time frame: Up to Week 10
Patients are instructed to produce five productions of /pa/ at their most comfortable pitch and loudness at a rate of approximately 1.5 syllables per second. The middle three productions will be analyzed to determine the average phonatory pressure.
Average Decibel (dB) Output during Aerodynamic Analysis of Voice
Time frame: Up to Week 10
Patients are instructed to produce five productions of /pa/ at their most comfortable pitch and loudness at a rate of approximately 1.5 syllables per second. The middle three productions will be analyzed to determine the average dB output.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No. This is a single institution study and all patient data will be limited to the primary research team
Related trials for Presbyphonia
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THE EFFECT OF POSTURAL ALİGNMENT AND DEEP CERVICAL MUSCLE TRAINING ON VOICE FUNCTION IN OLDER ADULTS WITH PRESBYPHONIA
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PhoRTE® Therapy Efficacy: In-Person Versus Telehealth
Atrophy of Vocal Cord, Presbyphonia
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Characterizing the Impact of Presbyphonia on Social Interaction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Johnson principal investigator
Aaron.Johnson@nyulangone.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine monohydrate in people with Presbyphonia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Voice Handicap Index (VHI)-10 Scores (time frame: Baseline, Week 10). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.