Characterizing the Impact of Presbyphonia on Social Interaction
Part of paid clinical trials in Iowa City, Iowa.
- Sponsor
- Matthew R. Hoffman
- Study ID
- NCT06441136
- Status
- Recruiting
Conditions
- Presbyphonia
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PhoRTE Program — OTHERSpeech therapy program guided by a speech language pathologist. This program includes in person or virtual visits and at home exercises.
- University of California Los Angeles (UCLA) Loneliness Scale — OTHERA questionnaire measuring levels of loneliness.
- Social Disconnectedness Scale — OTHERA questionnaire that asks about social network size and the frequency of social activities attended.
- Patient Health Questionnaire 9 — OTHERA questionnaire measuring levels of depression.
- Aging Voice Index — OTHERA questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults.
- The Edmonton Frail Scale — OTHERA questionnaire that measures frailty levels.
- Vocal Effort Scale — OTHERA picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice.
- Montreal Cognitive Assessment — OTHERA screening tool used to test for cognitive impairment.
- Voice Handicap Index-10 — OTHERA questionnaire used to measure quality of life impact of dysphonia.
- Voice Problem Impact Scales — OTHERA 4 question survey that captures impact of voice on four domains - work/daily activities, social life, home, and overall quality of life.
- Cough Severity Index — OTHERA 10 question survey asking to rate severity of cough.
- Laryngoscopy — PROCEDURENose 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.
- Acoustic, perceptual, and aerodynamic assessments — OTHERParticipants 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.
Study Details
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.
Key Dates
- Start date
- Jan 10, 2025
- Status verified
- Mar 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Phonation Resistance Training Exercises (PhoRTE) Voice Therapy ProgramPhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Primary Outcome Measure
The Effect on Loneliness with the PhoRTE Voice Therapy Program [ Time Frame: Baseline and at 3 months ]
Central Contacts
- Matthew R Hoffman, MD, PhD319-356-2201
- Emma L Thayer, BS319-678-7518
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 |
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