Impact of Age-Related Voice Change on Social Interaction

Overseen By Emma L Thayer, BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew R. Hoffman

Disqualifiers: Liquid dysphagia, Pneumonia, Neurologic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how changes in voice due to aging, known as presbyphonia, affect social interactions and feelings of loneliness or depression in older adults. Researchers will use questionnaires, voice assessments, and interviews to understand the impact of voice disorders and determine if voice therapy can enhance quality of life. The treatment involves a specific voice therapy program called PhoRTE, where participants perform vocal exercises to strengthen their voice muscles. Individuals diagnosed with presbyphonia and mild hearing loss, but without recent pneumonia or voice-related neurological issues, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving quality of life for older adults with voice changes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PhoRTE Program is safe for treating presbyphonia?

Research has shown that the PhoRTE voice therapy program is generally safe and well-tolerated for older adults with age-related voice issues. This therapy involves vocal exercises and improves voice quality without causing significant side effects. Participants typically perform these exercises at home and with a speech therapist, focusing on strengthening their voices.

Although studies have not reported any major side effects, individual experiences may vary. Evidence so far suggests that the PhoRTE program is a safe option for addressing age-related voice changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PhoRTE Program is unique because it specifically targets the muscular deficits in the vocal mechanism that occur with aging, a condition known as presbyphonia. Unlike traditional treatments, which might involve general voice therapy or surgery, PhoRTE uses targeted vocal exercises to increase the workload on the respiratory and laryngeal muscles. This approach is exciting because it offers a non-invasive method to potentially restore voice strength and quality by focusing on the underlying muscular changes, allowing for personalized intensity levels tailored to each participant's needs.

What evidence suggests that the PhoRTE Program is effective for presbyphonia?

Research has shown that the PhoRTE (Phonation Resistance Training Exercises) Program, which participants in this trial will undergo, can effectively improve voice quality in older adults with presbyphonia, a voice disorder caused by aging. Studies have found that participants in PhoRTE experienced significant improvements in their voice-related quality of life. Specifically, they achieved better scores on the Voice Handicap Index, which measures how much a voice disorder affects daily activities. The exercises in PhoRTE strengthen the muscles used for speaking, addressing the changes in the voice box that come with age. These improvements suggest that PhoRTE may help reduce the social impact of voice changes in older adults. ^{4 5 6 7 8}

Who Is on the Research Team?

Matthew R Hoffman, MD, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for older adults with presbyphonia, a voice disorder due to age-related changes in the larynx. Participants must have vocal fold atrophy but normal motion, be able to complete questionnaires and voice tasks, and have normal to mild hearing loss when using hearing aids.

Inclusion Criteria

Able to complete all questionnaires and voice assessment tasks

Normal to mild hearing loss in aided condition (with hearing aids)

I have been diagnosed with voice aging and confirmed vocal cord changes.

Exclusion Criteria

Montreal cognitive assessment score less than 26 or less than 25 if 12 or fewer years of formal education

I have had swallowing difficulties or pneumonia in the past year.

I have a neurological condition that affects my voice.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete questionnaires and voice assessments to establish baseline measures

1 day

1 visit (in-person)

PhoRTE Voice Therapy

Participants undergo PhoRTE voice therapy, practicing vocal exercises at home and meeting with a speech pathologist weekly

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in loneliness, social disconnectedness, and depression after therapy

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• PhoRTE Program

Trial Overview The study examines if presbyphonia affects social interaction. It involves completing various scales like the Edmonton Frail Scale and UCLA Loneliness Scale, undergoing laryngoscopy, participating in the PhoRTE Program for voice therapy, and other assessments of voice quality.

How Is the Trial Designed?

Group I: Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program Experimental Treatment 13 Interventions

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.

Who Is Running the Clinical Trial?

Matthew R. Hoffman

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24375313/

Preliminary data on two voice therapy interventions in the ... Results: Preliminary data revealed VFE and PhoRTE groups demonstrated a significant improvement in V-RQOL scores. However, only PhoRTE demonstrated a ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/76/NCT03696576/Prot_SAP_000.pdf

Phonation Resistance Training (PhoRTE) With And Without ... The aim of this study is to compare a voice therapy program developed specifically for patients diagnosed with presbyphonia, Phonation Resistant Training ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199721000771

Phonation Resistance Training Exercises (PhoRTE) With ... The primary outcome was change in Voice Handicap Index-10 (VHI-10). Secondary outcomes included the Aging Voice Index, maximum expiratory pressure, and acoustic ...

4. phorte.org phorte.org/research/

Research This grant supports innovative research that explores the effectiveness and benefits of PhoRTE® in managing voice, motor speech, and swallowing disorders.

5. uab.edu uab.edu/medicine/otolaryngology/images/documents/Preliminary_data_on_two_voice_therapy_interventions_in_the_treatment_of_presbyphonia.pdf

Preliminary_data_on_two_voice... Conclusions: Findings provide new evidence regarding the efficacy of voice therapy exercises in the treatment of age- related dysphonia and suggest PhoRTE ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06934265?term=Otolaryngology

PhoRTE® Therapy Efficacy: In-Person Versus Telehealth This study compares how well voice therapy works when delivered in-person versus through telehealth for older adults with age-related voice problems.

7. pubs.asha.org pubs.asha.org/doi/10.1044/2022_PERSP-22-00023

Reframing Aging Voice and Presbyphonia: What Else Can ... A study comparing the PhoRTE, VFE, and control groups found improved voice-related quality of life in the PhoRTE and VFE groups and decreased ...

8. phorte.org phorte.org/

PhoRTE Voice Therapy: Home PhoRTE is voice therapy for age-related voice changes using high intensity vocal exercise, with limited sessions and 12-15 minutes of home practice.