Creatine Supplementation for Improved Voice Performance in the Elderly

NYU Langone Health

Status: Suspended

Conditions: Presbyphonia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Creatine monohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05856916

22-01536

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 65 years or older
2. Desiring to participate in voice therapy

Exclusion criteria

1. Lesions or abnormalities of the larynx not attributable to normal aging
2. Pre-existing renal disease
3. Pre-existing liver disease
4. Congestive heart failure
5. 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
6. Concurrent medication associated with reduced renal clearance (e.g. Nonsteroidal Anti-inflammatory Drugs (NSAIDs), metformin)
7. History of prior vocal fold augmentation procedures
8. Cognitive disability
9. Unwillingness to participate in voice therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Creatine Supplementation

Experimental group

Description:

Participants randomized to receive creatine. Study participants will be asked to track their daily administration on a log provided by the study team.

Treatment:

Dietary Supplement: Creatine monohydrate

Placebo

Placebo Comparator group

Description:

Participants randomized to receive placebo. Study participants will be asked to track their daily administration on a log provided by the study team.

Treatment:

Dietary Supplement: Placebo