Presbyphonia
Conditions
Keywords
creatine, presbyphonia, presbylarynx, vocal atrophy
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.
Interventions
DIETARY_SUPPLEMENTCreatine monohydrate
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Voice Handicap Index (VHI)-10 Scores | Baseline, Week 10 | 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. |
| Average Expert Rating of Change in Mucosal Wave | Week 10 | 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). |
| Average Expert Rating of Change in Vocal Fold Atrophy | Week 10 | 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). |
| Average Expert Rating of Change in Glottal Closure | Week 10 | 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). |
| Average Phonatory Pressure during Aerodynamic Analysis of Voice | Up to Week 10 | 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. |
| Average Decibel (dB) Output during Aerodynamic Analysis of Voice | Up to Week 10 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAaron Johnson
Aaron.Johnson@nyulangone.org
Outcome results
None listed