Creatine Supplementation for Improved Voice Performance in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Average Decibel (dB) Output during Aerodynamic Analysis of Voice
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Desiring to participate in voice therapy
排除标准
- •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
研究组 & 干预措施
Creatine Supplementation
Participants randomized to receive creatine. Study participants will be asked to track their daily administration on a log provided by the study team.
干预措施: Creatine monohydrate (Dietary Supplement)
Placebo
Participants randomized to receive placebo. Study participants will be asked to track their daily administration on a log provided by the study team.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Average Decibel (dB) Output during Aerodynamic Analysis of Voice
时间窗: 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.
Average Expert Rating of Change in Mucosal Wave
时间窗: 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 Glottal Closure
时间窗: 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
时间窗: 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 Expert Rating of Change in Vocal Fold Atrophy
时间窗: 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).
Change from Baseline in Voice Handicap Index (VHI)-10 Scores
时间窗: 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.
次要结局
未报告次要终点