Creatine Supplementation for Improved Voice Performance in the Elderly

Study Overview
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Brief Summary
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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
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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.

Official Title
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Creatine Supplementation for Improved Voice Performance in the Elderly

Conditions
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Presbyphonia

Intervention / Treatment
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* Dietary Supplement: Creatine monohydrate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 years or older Desiring to participate in voice therapy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creatine Supplementation<br>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<br>* 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.<br>* Other names: Creapure;|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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creatine, presbyphonia, presbylarynx, vocal atrophy