Characterizing the Impact of Presbyphonia on Social Interaction

NCT06441136 | Recruiting DMC

• 1 other identifier: 202307188
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

voice therapy; aging voice; voice disorder; speech

Outcome Measures

Primary Outcomes (1)

• The Effect on Loneliness with the PhoRTE Voice Therapy Program

  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.

  Baseline and at 3 months

Secondary Outcomes (2)

• The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program

  Baseline and at 3 months

• The Effect on Depression with the PhoRTE Voice Therapy Program

  Baseline and at 3 months

Study Arms (1)

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

EXPERIMENTAL

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.

Other: PhoRTE Program; Other: University of California Los Angeles (UCLA) Loneliness Scale; Other: Social Disconnectedness Scale; Other: Patient Health Questionnaire 9; Other: Aging Voice Index; Other: The Edmonton Frail Scale; Other: Vocal Effort Scale; Other: Montreal Cognitive Assessment; Other: Voice Handicap Index-10; Other: Voice Problem Impact Scales; Other: Cough Severity Index; Procedure: Laryngoscopy; Other: Acoustic, perceptual, and aerodynamic assessments

Interventions

PhoRTE Program OTHER

Speech therapy program guided by a speech language pathologist. This program includes in person or virtual visits and at home exercises.

Also known as: Speech Therapy Program

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

University of California Los Angeles (UCLA) Loneliness Scale OTHER

A questionnaire measuring levels of loneliness.

Also known as: UCLA Loneliness Scale

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Social Disconnectedness Scale OTHER

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

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Patient Health Questionnaire 9 OTHER

A questionnaire measuring levels of depression.

Also known as: PHQ-9

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Aging Voice Index OTHER

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

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

The Edmonton Frail Scale OTHER

A questionnaire that measures frailty levels.

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Vocal Effort Scale OTHER

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

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Montreal Cognitive Assessment OTHER

A screening tool used to test for cognitive impairment.

Also known as: MOCA

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Voice Handicap Index-10 OTHER

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

Also known as: VHI-10

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Voice Problem Impact Scales OTHER

A 4 question survey that captures impact of voice on four domains - work/daily activities, social life, home, and overall quality of life.

Also known as: VPIS

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Cough Severity Index OTHER

A 10 question survey asking to rate severity of cough.

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Laryngoscopy PROCEDURE

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.

Also known as: Flexible transnasal videostroboscopy

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Acoustic, perceptual, and aerodynamic assessments OTHER

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.

Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthew R. Hoffman: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

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MeSH Terms

Conditions

Voice Disorders; Speech

Interventions

Patient Health Questionnaire; Mental Status and Dementia Tests; Laryngoscopy

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Neuropsychological Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Matthew R Hoffman, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew R Hoffman, MD, PhD

CONTACT

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

Emma L Thayer, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after study completion
• Access Criteria: email principal investigator a non-disclosure and/or data usage agreement will most likely be required

Locations

US (1)