Recruiting

Observational Study

Sponsor:

Matthew R. Hoffman

Code:

NCT06441136

Conditions

Presbyphonia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

PhoRTE Program

University of California Los Angeles (UCLA) Loneliness Scale

Social Disconnectedness Scale

Patient Health Questionnaire 9

Aging Voice Index

Study Details

Brief summary:

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.

Conditions

Presbyphonia

Study ID

NCT06441136

Start date

Jan 10, 2025

Status verified date

Mar, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

PhoRTE 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.

Interventions

PhoRTE Program

Speech 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

A questionnaire measuring levels of loneliness.

Social Disconnectedness Scale

A questionnaire that asks about social network size and the frequency of social activities attended.

Patient Health Questionnaire 9

A questionnaire measuring levels of depression.

Aging Voice Index

A questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults.

The Edmonton Frail Scale

A questionnaire that measures frailty levels.

Vocal Effort Scale

A picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice.

Montreal Cognitive Assessment

A screening tool used to test for cognitive impairment.

Voice Handicap Index-10

A questionnaire used to measure quality of life impact of dysphonia.

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.

Cough Severity Index

A 10 question survey asking to rate severity of cough.

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.

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 measure

  • The Effect on Loneliness with the PhoRTE Voice Therapy Program [ Time Frame: Baseline and at 3 months ]

Central Contacts and Locations

Central contacts

Matthew R Hoffman, MD, PhD

319-356-2201matthew-r-hoffman@uiowa.edu

Emma L Thayer, BS

319-678-7518emma-thayer@uiowa.edu

Locations

University of Iowa Hospitals & Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Emma L Thayer, BS

515-371-7676emma-thayer@uiowa.edu

More Information

Sponsor

Matthew R. Hoffman

Last update posted

Jul 17, 2025

Last verified

Mar, 2025

Keywords

  • voice therapy
  • aging voice
  • voice disorder
  • speech

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Matthew R. Hoffman on 2025-07-17.