Characterizing the Impact of Presbyphonia on Social Interaction

July 14, 2025 updated by: Matthew R. Hoffman
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

During the study visit, all subjects (including the control group) will be given ten questionnaires asking them to rate their loneliness and quality of life in relation to the changes in their voice. All participants will undergo audiometry to assess hearing (with hearing aids if used at home). If they do not pass the hearing test, they will be screened out of the study.

Participants will then provide a required voice sample using sustained vowels for 3-5 seconds 5 times each, repeating six standard sentences, and 20 seconds of natural conversational speech. Using this voice recording, the following assessments and measurements will be obtained: CAPE-V rating (Consensus auditory perceptual evaluation of voice), Cepstral peak prominence (measurement of dysphonia), fundamental frequency, signal-to-noise ratio, and voice type components (captures breathiness).

Subjects will then be asked to produce a train of /pi pi pi/ at a comfortable pitch and loudness into a mask with an intra-oral mouthpiece to record both pressure and airflow. Five trials will be performed. The following measurements will be obtained: mean flow rate, subglottal pressure, and vocal efficiency.

Subjects will then undergo an awake videostroboscopy using a small flexible camera passed through the nose to view the vocal folds. During this procedure, the nose is anesthetized and the subject is asked to produce sustained vowels for 3-5 seconds. This part of the study takes about 2 minutes to complete. The parameters to be measured for this are: bowing index of the vocal folds and normalized glottal gap.

For the second part of this study, subjects from the presbyphonia population only will be recruited to participate in the phonation resistance training exercises or PhoRTE voice therapy. Prior to therapy, for two weeks, participants will take pictures when their voice disorder may be affecting them or ability to socialize. Brief journal entry will be completed. Photos will be collected, printed, and used as memory recall tool for a pre-treatment semi-structured interview. Interviews will be conducted, approximately 45-60 minutes induration. Both online and in-person options will be available to facilitate participation. An interview guide will include questions designed to assess participants' perception of voice and how voice affects social participation.

Subjects will then complete PhoRTE therapy. Participants perform 5 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.

Following therapy, participants will participate in 60-75-minute semi-structured small group interviews approximately 3 months after voice therapy. Interviews will address experience with voice therapy, and any changes after voice therapy.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals & Clinics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Speech Therapy Program
Other: University of California Los Angeles (UCLA) Loneliness Scale
A questionnaire measuring levels of loneliness.
Other Names:
  • UCLA Loneliness Scale
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 Names:
  • PHQ-9
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 Names:
  • MOCA
Other: Voice Handicap Index-10
A questionnaire used to measure quality of life impact of dysphonia.
Other Names:
  • VHI-10
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 Names:
  • VPIS
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 Names:
  • Flexible transnasal videostroboscopy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program
Time Frame: Baseline and at 3 months
Social disconnectedness will be measured using the Social Disconnectedness Scale questionnaire at baseline and at the end of the 4 week PhoRTE program. The Social Disconnectedness Scale is based on a 15-item scale with each item rated on their own scale depending on the question asked (ex: ranging from 0, "never" to 7, "several times a week" or indicating number of individuals in a social network). The total score can range from 2 to 72, with lower scores indicating greater levels of social disconnectedness.
Baseline and at 3 months
The Effect on Depression with the PhoRTE Voice Therapy Program
Time Frame: Baseline and at 3 months
Levels of depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and at the end of the 4 week PhoRTE program. The PHQ-9 is a 9-item scale with each item rated on a scale (ranging from 0, "not at all," to 3, "nearly every day") and the total score can range from 0-27 with higher scores indicating greater feelings of depression.
Baseline and at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthew R. Hoffman

Investigators

  • Principal Investigator: Matthew R Hoffman, MD, PhD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202307188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any data or resources, shared upon request, will be de-identified and released only after appropriate data sharing agreements are completed by the relevant parties. Users must agree to the conditions of use governing access to the public release data. This includes restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, proper acknowledgement of the data resource, information provided to users will not be used for commercial purposes, and will not be redistributed to third parties.

IPD Sharing Time Frame

after study completion

IPD Sharing Access Criteria

email principal investigator

a non-disclosure and/or data usage agreement will most likely be required

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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