Creatine Supplementation for Improved Voice Performance in the Elderly

NCT05856916 | Suspended

• 1 other identifier: 22-01536
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Presbyphonia

Keywords

creatine; presbyphonia; presbylarynx; vocal atrophy

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  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).

  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).

  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.

  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.

  Up to Week 10

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

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.

Also known as: Creapure

Creatine Supplementation

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Desiring to participate in voice therapy

You may not qualify if:

• 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)
• History of prior vocal fold augmentation procedures
• Cognitive disability
• Unwillingness to participate in voice therapy

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Aaron Johnson

  Aaron.Johnson@nyulangone.org

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)