PresbyphoniaNCT06441136
Characterizing the Impact of Presbyphonia on Social Interaction
A study testing PhoRTE Program, University of California Los Angeles (UCLA) Loneliness Scale and Social Disconnectedness Scale in people with Presbyphonia, run by Matthew R. Hoffman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Presbyphonia
- What is being tested?
- PhoRTE Program, University of California Los Angeles (UCLA) Loneliness Scale and Social Disconnectedness Scale
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Emma L Thayer, BS, 515-371-7676, emma-thayer@uiowa.edu
About this study
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.
Read the 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
- Being tested
- PhoRTE Program, University of California Los Angeles (UCLA) Loneliness Scale, Social Disconnectedness Scale, Patient Health Questionnaire 9, Aging Voice Index
- Keywords
- voice therapy, aging voice, voice disorder, speech
- Medical subject headings
- Voice Disorders, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhoRTE ProgramOther
Also called Speech Therapy Program
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 ScaleOther
Also called UCLA Loneliness Scale
A questionnaire measuring levels of loneliness.
Social Disconnectedness ScaleOther
A questionnaire that asks about social network size and the frequency of social activities attended.
Patient Health Questionnaire 9Other
Also called PHQ-9
A questionnaire measuring levels of depression.
Aging Voice IndexOther
A questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults.
The Edmonton Frail ScaleOther
A questionnaire that measures frailty levels.
Vocal Effort ScaleOther
A picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice.
Montreal Cognitive AssessmentOther
Also called MOCA
A screening tool used to test for cognitive impairment.
Voice Handicap Index-10Other
Also called VHI-10
A questionnaire used to measure quality of life impact of dysphonia.
Voice Problem Impact ScalesOther
Also called VPIS
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 IndexOther
A 10 question survey asking to rate severity of cough.
LaryngoscopyProcedure or surgery
Also called Flexible transnasal videostroboscopy
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 assessmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 3 months
Secondary outcomes (2)
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.
Measured: Baseline and at 3 months
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.
Measured: Baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Jan 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for PresbyphoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew R. Hoffman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew R. Hoffman, University of Iowa
- Investigators
- Matthew R Hoffman, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441136
- Sponsor's protocol ID
- 202307188
- Status last verified
- Mar 2025
- First submitted
- 28 May 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 19891523Baertsch 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.
PubMed 36111826Baker TA, Wang CC. Photovoice: use of a participatory action research method to explore the chronic pain experience in older adults. Qual Health Res. 2006 Dec;16(10):1405-13. doi: 10.1177/1049732306294118.
PubMed 17079801Belsky 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.
PubMed 31932188Belsky 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.
PubMed 33741235Cacioppo 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.
PubMed 16594799Catalani 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.
PubMed 19797541Chan 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.
PubMed 27649217Cohen SM. Self-reported impact of dysphonia in a primary care population: an epidemiological study. Laryngoscope. 2010 Oct;120(10):2022-32. doi: 10.1002/lary.21058.
PubMed 20830762Cornwell EY, Waite LJ. Social disconnectedness, perceived isolation, and health among older adults. J Health Soc Behav. 2009 Mar;50(1):31-48. doi: 10.1177/002214650905000103.
PubMed 19413133Etter NM, Hapner ER, Barkmeier-Kraemer JM, Gartner-Schmidt JL, Dressler EV, Stemple JC. Aging Voice Index (AVI): Reliability and Validity of a Voice Quality of Life Scale for Older Adults. J Voice. 2019 Sep;33(5):807.e7-807.e12. doi: 10.1016/j.jvoice.2018.04.006. Epub 2018 May 7.
PubMed 29748025Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Gilman M, Merati AL, Klein AM, Hapner ER, Johns MM. Performer's attitudes toward seeking health care for voice issues: understanding the barriers. J Voice. 2009 Mar;23(2):225-8. doi: 10.1016/j.jvoice.2007.08.003. Epub 2007 Nov 26.
PubMed 18037270Giua R, Pedone C, Scarlata S, Carrozzo I, Rossi FF, Valiani V, Incalzi RA. Relationship between respiratory muscle strength and physical performance in elderly hospitalized patients. Rejuvenation Res. 2014 Aug;17(4):366-71. doi: 10.1089/rej.2014.1549.
PubMed 24749768Golub JS, Chen PH, Otto KJ, Hapner E, Johns MM 3rd. Prevalence of perceived dysphonia in a geriatric population. J Am Geriatr Soc. 2006 Nov;54(11):1736-9. doi: 10.1111/j.1532-5415.2006.00915.x.
PubMed 17087701
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Impact of Presbyphonia on Social Interaction
- ClinicalTrials.gov ID
- NCT06441136
- Acronym / sponsor ID
- 202307188
- Conditions
- Presbyphonia
- Keywords
- voice therapy, aging voice, voice disorder, speech
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Matthew R. HoffmanUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program | Experimental | 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 assessmentsPhoRTE 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhoRTE ProgramAlso: Speech Therapy ProgramSpeech therapy program guided by a speech language pathologist. This program includes in person or virtual visits and at home exercises. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| University of California Los Angeles (UCLA) Loneliness ScaleAlso: UCLA Loneliness ScaleA questionnaire measuring levels of loneliness. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Social Disconnectedness ScaleA questionnaire that asks about social network size and the frequency of social activities attended. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Patient Health Questionnaire 9Also: PHQ-9A questionnaire measuring levels of depression. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Aging Voice IndexA questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| The Edmonton Frail ScaleA questionnaire that measures frailty levels. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Vocal Effort ScaleA picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Montreal Cognitive AssessmentAlso: MOCAA screening tool used to test for cognitive impairment. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Voice Handicap Index-10Also: VHI-10A questionnaire used to measure quality of life impact of dysphonia. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Voice Problem Impact ScalesAlso: VPISA 4 question survey that captures impact of voice on four domains - work/daily activities, social life, home, and overall quality of life. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Cough Severity IndexA 10 question survey asking to rate severity of cough. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| LaryngoscopyAlso: Flexible transnasal videostroboscopyNose 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. | Procedure or surgery | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
| Acoustic, perceptual, and aerodynamic assessmentsParticipants 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. | Other | Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program |
Primary outcome
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.
2 secondary outcomes
The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program
Time frame: Baseline and at 3 months
The Effect on Depression with the PhoRTE Voice Therapy Program
Time frame: Baseline and at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 19891523Awan 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.
- Background: PubMed 36111826Baertsch 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.
- Background: PubMed 17079801Baker TA, Wang CC. Photovoice: use of a participatory action research method to explore the chronic pain experience in older adults. Qual Health Res. 2006 Dec;16(10):1405-13. doi: 10.1177/1049732306294118.
- Background: PubMed 31932188Belsky 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.
- Background: PubMed 33741235Belsky 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.
- Background: PubMed 16594799Cacioppo 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.
- Background: PubMed 19797541Catalani 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.
- Background: PubMed 27649217Chan 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.
- Background: PubMed 20830762Cohen SM. Self-reported impact of dysphonia in a primary care population: an epidemiological study. Laryngoscope. 2010 Oct;120(10):2022-32. doi: 10.1002/lary.21058.
- Background: PubMed 19413133Cornwell EY, Waite LJ. Social disconnectedness, perceived isolation, and health among older adults. J Health Soc Behav. 2009 Mar;50(1):31-48. doi: 10.1177/002214650905000103.
- Background: PubMed 29748025Etter NM, Hapner ER, Barkmeier-Kraemer JM, Gartner-Schmidt JL, Dressler EV, Stemple JC. Aging Voice Index (AVI): Reliability and Validity of a Voice Quality of Life Scale for Older Adults. J Voice. 2019 Sep;33(5):807.e7-807.e12. doi: 10.1016/j.jvoice.2018.04.006. Epub 2018 May 7.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Individual participant dataSharing planned: Yes. 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.
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Atrophy of Vocal Cord, Presbyphonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew R Hoffman, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PhoRTE Program, University of California Los Angeles (UCLA) Loneliness Scale and Social Disconnectedness Scale in people with Presbyphonia, run by Matthew R. Hoffman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew R Hoffman, MD, PhD (319-356-2201, matthew-r-hoffman@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect on Loneliness with the PhoRTE Voice Therapy Program (time frame: Baseline and at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06441136, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.