NCT06441136 · Matthew R. Hoffman
Characterizing the Impact of Presbyphonia on Social Interaction
What this study is about
The purpose of this study is to determine if presbyphonia, or voice disorder caused by age-related change in the larynx, is associated with change in social interaction. This proposal investigates the impact of voice impairment in older adults on social interaction, loneliness, social disconnectedness, and depression.
View original scientific description
The purpose of this study is to determine if presbyphonia, or voice disorder caused by age-related change in the larynx, is associated with change in social interaction. This proposal investigates the impact of voice impairment in older adults on social interaction, loneliness, social disconnectedness, and depression. A series of questionnaires, voice assessments, and interviews will be performed to improve our understanding of how voice disorders affect older adults and how treatment of voice impairment with voice therapy may improve quality of life.
Interventions
OTHER
PhoRTE Program
Speech therapy program guided by a speech language pathologist. This program includes in person or virtual visits and at home exercises.
OTHER
University of California Los Angeles (UCLA) Loneliness Scale
A questionnaire measuring levels of loneliness.
OTHER
Social Disconnectedness Scale
A questionnaire that asks about social network size and the frequency of social activities attended.
OTHER
Patient Health Questionnaire 9
A questionnaire measuring levels of depression.
OTHER
Aging Voice Index
A questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults.
OTHER
The Edmonton Frail Scale
A questionnaire that measures frailty levels.
OTHER
Vocal Effort Scale
A picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice.
OTHER
Montreal Cognitive Assessment
A screening tool used to test for cognitive impairment.
OTHER
Voice Handicap Index-10
A questionnaire used to measure quality of life impact of dysphonia.
OTHER
Voice Problem Impact Scales
A 4 question survey that captures impact of voice on four domains - work/daily activities, social life, home, and overall quality of life.
OTHER
Cough Severity Index
A 10 question survey asking to rate severity of cough.
PROCEDURE
Laryngoscopy
Nose is anesthetized and a flexible endoscope is passed to visualize the larynx at rest and during sustained vowel production (/i/) for 3-5 seconds. This will be used to measure bowing index and normalized glottal gap of the vocal folds.
OTHER
Acoustic, perceptual, and aerodynamic assessments
Participants will complete voice recording tasks including sustained vowel production, six standard sentences, and 20 seconds of natural conversational speech. This will be used to measure CAPE-V rating, Cepstral peak prominence, fundamental frequency, signal-to-noise ratio, voice type components, mean flow rate, subglottal pressure, and vocal efficiency.
Primary outcome measures
The Effect on Loneliness with the PhoRTE Voice Therapy Program
Time frame: Baseline and at 3 months
Loneliness will be measured using the University of California - Los Angeles (UCLA) Loneliness Scale questionnaire at baseline and at the end of the 4-week PhoRTE program. The UCLA Loneliness Scale is a 20-item scale with each item rated on a 4-point Likert scale (ranging from 1, "never," to 4, "often") and the total score can range from 20 to 80, with higher scores indicating greater feelings of loneliness.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of presbyphonia with findings of presbylaryngis on videostroboscopy, with findings of bilateral true vocal fold atrophy and normal vocal fold motion bilaterally
- Able to complete all questionnaires and voice assessment tasks
- Normal to mild hearing loss in aided condition (with hearing aids)
Exclusion criteria
- Liquid dysphagia or pneumonia in the last year
- Vocal fold lesion/scar/motion impairment
- Neurologic disorder affecting the voice
- Montreal cognitive assessment score \<26 or \<25 if 12 or fewer years of formal education
Where
- Iowa City, Iowa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2025 · Source of record for eligibility and locations