NCT06441136

Characterizing the Impact of Presbyphonia on Social Interaction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Matthew R. Hoffman · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Presbyphonia

Interventions

Type	Name	Description
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	University of California Los Angeles (UCLA) Loneliness Scale	A questionnaire measuring levels of loneliness.
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	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	Voice Handicap Index-10	A questionnaire used to measure quality of life impact of dysphonia.
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	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	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.

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2024-06-04
• Last updated: 2025-07-17

Locations

1 site across 1 country: United States