Clinical trial NCT05856916: Creatine Supplementation for Improved Voice Performance in the Elderly
Official title: Creatine Supplementation for Improved Voice Performance in the Elderly
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Presbyphonia
Keywords: creatine
presbyphonia
presbylarynx
vocal atrophy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Voice Handicap Index (VHI)-10 Scores
timeFrame: Baseline, Week 10
measure: Average Expert Rating of Change in Mucosal Wave
timeFrame: Week 10
measure: Average Expert Rating of Change in Vocal Fold Atrophy
timeFrame: Week 10
measure: Average Expert Rating of Change in Glottal Closure
timeFrame: Week 10
measure: Average Phonatory Pressure during Aerodynamic Analysis of Voice
timeFrame: Up to Week 10
measure: Average Decibel (dB) Output during Aerodynamic Analysis of Voice
timeFrame: Up to Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: Aaron.Johnson@nyulangone.org
name: Aaron Johnson
role: PRINCIPAL_INVESTIGATOR
References: