Characterizing the Impact of Presbyphonia on Social Interaction

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое PhoRTE Program
  Speech therapy program guided by a speech language pathologist. This program includes in person or virtual visits and at home exercises.
• Другое University of California Los Angeles (UCLA) Loneliness Scale
  A questionnaire measuring levels of loneliness.
• Другое Social Disconnectedness Scale
  A questionnaire that asks about social network size and the frequency of social activities attended.
• Другое Patient Health Questionnaire 9
  A questionnaire measuring levels of depression.
• Другое Aging Voice Index
  A questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults.
• Другое The Edmonton Frail Scale
  A questionnaire that measures frailty levels.
• Другое Vocal Effort Scale
  A picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice.
• Другое Montreal Cognitive Assessment
  A screening tool used to test for cognitive impairment.
• Другое Voice Handicap Index-10
  A questionnaire used to measure quality of life impact of dysphonia.
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (2)

• The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program [Срок оценки: Baseline and at 3 months]
• The Effect on Depression with the PhoRTE Voice Therapy Program [Срок оценки: Baseline and at 3 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Iowa Hospitals & Clinics — Iowa City

Публикации

• Awan SN, Roy N, Dromey C. Estimating dysphonia severity in continuous speech: application of a multi-parameter spectral/cepstral model. Clin Linguist Phon. 2009 Nov;23(11):825-41. doi: 10.3109/02699200903242988. PMID 19891523
• Baertsch HC, Bhatt NK, Giliberto JP, Dixon C, Merati AL, Sauder C. Quantification of Vocal Fold Atrophy in Age-Related and Parkinson's Disease-Related Vocal Atrophy. Laryngoscope. 2023 Jun;133(6):1462-1469. doi: 10.1002/lary.30394. Epub 2022 Sep 16. PMID 36111826
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• Belsky MA, Rothenberger SD, Gillespie AI, Gartner-Schmidt JL. Do Phonatory Aerodynamic and Acoustic Measures in Connected Speech Differ Between Vocally Healthy Adults and Patients Diagnosed with Muscle Tension Dysphonia? J Voice. 2021 Jul;35(4):663.e1-663.e7. doi: 10.1016/j.jvoice.2019.12.019. Epub 2020 Jan 10. PMID 31932188
• Belsky MA, Shelly S, Rothenberger SD, Ziegler A, Hoffman B, Hapner ER, Gartner-Schmidt JL, Gillespie AI. Phonation Resistance Training Exercises (PhoRTE) With and Without Expiratory Muscle Strength Training (EMST) For Patients With Presbyphonia: A Noninferiority Randomized Clinical Trial. J Voice. 2023 May;37(3):398-409. doi: 10.1016/j.jvoice.2021.02.015. Epub 2021 Mar 16. PMID 33741235
• Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006 Mar;21(1):140-51. doi: 10.1037/0882-7974.21.1.140. PMID 16594799
• Catalani C, Minkler M. Photovoice: a review of the literature in health and public health. Health Educ Behav. 2010 Jun;37(3):424-51. doi: 10.1177/1090198109342084. Epub 2009 Oct 1. PMID 19797541
• Chan AW, Chan HY, Chan IK, Cheung BY, Lee DT. An Age-Friendly Living Environment as Seen by Chinese Older Adults: A "Photovoice" Study. Int J Environ Res Public Health. 2016 Sep 13;13(9):913. doi: 10.3390/ijerph13090913. PMID 27649217

Идентификаторы

NCT: NCT06441136 · 202307188

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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