Clinical Trials Directory

Trials / Suspended

SuspendedNCT05856916

Creatine Supplementation for Improved Voice Performance in the Elderly

Status
Suspended
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
NYU Langone Health · Academic / Other
Sex
All
Age
65 Years – 100 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCreatine monohydrateCreatine 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_SUPPLEMENTPlaceboPlacebo (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.

Timeline

Start date
2026-05-01
Primary completion
2026-06-01
Completion
2026-09-01
First posted
2023-05-12
Last updated
2026-03-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05856916. Inclusion in this directory is not an endorsement.