Health TrialsbyHealthPanel

Characterizing the Impact of Presbyphonia on Social Interaction

ConditionPresbyphonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMatthew R. Hoffman

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • PhoRTE Program

    Other intervention

    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

    Other intervention

    A questionnaire measuring levels of loneliness.

  • Social Disconnectedness Scale

    Other intervention

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

  • Patient Health Questionnaire 9

    Other intervention

    A questionnaire measuring levels of depression.

  • Aging Voice Index

    Other intervention

    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

    Other intervention

    A questionnaire that measures frailty levels.

  • Vocal Effort Scale

    Other intervention

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

  • Montreal Cognitive Assessment

    Other intervention

    A screening tool used to test for cognitive impairment.

  • Voice Handicap Index-10

    Other intervention

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

  • Voice Problem Impact Scales

    Other intervention

    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

    Other intervention

    A 10 question survey asking to rate severity of cough.

  • Laryngoscopy

    Procedure/Surgery

    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

    Other intervention

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Phonation Resistance Training Exercises (PhoRTE) Voice Therapy ProgramExperimental treatment 13 interventions

Trial outcomes

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.

Time frame
Baseline and at 3 months

Secondary outcomes

1

The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program

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.

Time frame
Baseline and at 3 months
2

The Effect on Depression with the PhoRTE Voice Therapy Program

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.

Time frame
Baseline and at 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matthew R. Hoffman

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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