Voice DisorderNCT03696576
Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy
A study testing EMST and PhoRTE in people with Voice Disorder and Vocal Cord Atrophy, run by Emory University at 2 sites in United States.
Trial summary
The larynx and vocal folds undergo many age-related changes in their physiology and structure that can lead to undesirable effects on the voice, with changes in the respiratory system compounding these deficits. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Voice Disorder, Vocal Cord Atrophy, Presbyphonia
- What is being tested?
- EMST and PhoRTE
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2018to 4 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 or older
- Diagnosis of presbyphonia (vocal fold atrophy) made by a fellowship-trained laryngologist and a voice specialized speech language pathologist
- Willingness to be randomized to one of two treatments
Who cannot join
- Any concomitant laryngeal diagnoses or diseases known to affect voice function, including: amyloidosis, arytenoid dislocation, laryngeal cancer, cricoarytenoid fixation, vocal fold cyst(s), vocal nodules, vocal fold polyp(s), dysplasia, vocal fold fibrous mass(es), glottal web, vocal fold immobility, laryngeal stenosis, laryngocele, leukoplakia, Parkinson's disease, Reinke's edema, respiratory recurrent pneumonia, sarcoidosis, spasmodic dysphonia
- Any chronic lower airway disease such as chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, emphysema, cystic fibrosis
- History of acute stroke
- Untreated hypertension
- Untreated gastroesophageal reflux disease (GERD)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
University of Pittsburgh Voice Center
Pittsburgh, Pennsylvania, 15219
About this study
Official title: EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy
The larynx and vocal folds undergo many age-related changes in their physiology and structure that can lead to undesirable effects on the voice, with changes in the respiratory system compounding these deficits. These changes, also called presbyphonia, can have serious detrimental effects on the lives of elderly individuals. There are few studies that have evaluated the use of voice therapy treatment options for these patients. The primary aim of this study is to test whether the addition of expiratory muscle strength training (EMST) to a current, validated voice therapy protocol aimed at treating presbyphonia, (phonation resistance training, PhoRTE) can improve outcomes of therapy.
Read the detailed description
The purpose of this study is to test whether the addition of EMST to PhoRTE Voice Therapy is at least as effective as PhoRTE alone for improving acoustic, aerodynamic, and patient-reported outcomes in patients affected by age-related vocal fold atrophy.
Voice therapy is often the first-line treatment for patients experiencing presbyphonia. Despite being the most common treatment for presbyphonia, scant literature exists on the efficacy of voice therapy for these patients. The current proposal aims to add to this growing body of literature. In general, studies of existing voice therapy programs for presbyphonia have demonstrated success in achieving improvement in aerodynamic (increased subglottal pressure), acoustic (increased shimmer, jitter, and decreased noise-to-harmonics ratio), and patient-centered outcomes (reduction in Voice Handicap Index scores, decreased phonatory effort). Ziegler et al. conducted a study comparing a standard voice therapy, Vocal Function Exercises (VFE) and Phonation Resistance Training Exercises (PhoRTE) and found that both therapies improved outcomes of voice-related quality of life, but only PhoRTE gave a statistically significant reduction in perceived phonatory effort. A specific therapy designed to address age-related changes to respiratory system is expiratory muscle strength training (EMST). EMST devices are loaded with a resistive spring which opens when a desired level of expiratory pressure is reached and maintained. Maintenance of consistent subglottal pressure is the foundation for phonation. EMST device training improves active expiratory muscle forces required for high-pressure activities such as long utterances or loud speech in vocally healthy individuals. When used in conjunction with traditional voice therapy, EMST use has also shown to increase maximum phonation time, maximum expiratory pressure, dynamic range, subglottal pressure, and perception of voice handicap in professional voice users over traditional voice therapy alone. The theoretical underpinnings for treatment of vocal fold atrophy with EMST are clear, as it addresses many of the common goals of treatment in patients with presbyphonia, but it has not yet been tested as a possible adjunctive treatment for patients undergoing voice therapy.
- Conditions
- Voice Disorder, Vocal Cord Atrophy, Presbyphonia
- Being tested
- EMST, PhoRTE
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMSTDevice
Training of the respiratory system muscles using the EMST device.
PhoRTEBehavioural
Completing of PhoRTE voice therapy.
| Study group | Role | What they receive |
|---|---|---|
| PhoRTE | Active comparator | This group will undergo standard PhoRTE therapy. Receives: Behavioral: PhoRTE |
| PhoRTE + EMST | Experimental | This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device. Receives: Device: EMST; Behavioral: PhoRTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Handicap Index-10 (VHI-10) Score
The Voice Handicap Index-10 (VHI-10) is a validated assessment instrument that quantifies patient perceptions of his or her own voice handicap. A lower score on the VHI-10 indicates perception of a lesser voice handicap than a high score. Scores range from 0 to 40.
Measured: At each study visit through study completion; Time 0 (therapy visit 1-Baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)
Secondary outcomes (12)
AVI Score at Baseline and Follow up (5 Weeks)
The Aging Voice Index (AVI) is a validated instrument that measures quality of life in older adults with voice disorders. A higher score indicates worse quality of life. Scores range from 0 to 92.
Measured: At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)
Maximum Expiratory Pressure (MEP)
Maximum Expiratory Pressure (MEP) was measured using a handheld manometer (Micro Direct Respiratory Pressure Meter, MicroRPM, Med-Electronics, Beltsville, MD, United States) at baseline and after 5 weeks of therapy. Participants were instructed to blow with maximum force into the MicroRPM device over 10 trials, and the participant's best three trials were used to calculate their average MEP.
Measured: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Phonatory Airflow in Speech at Baseline and 5 Weeks
Aerodynamic measures were collected and analyzed via the Phonatory Aerodynamic System 6600 (PAS; PENTAX Medical, Montvale, NJ, United States) using the first four sentences of the Rainbow Passage. Aerodynamic measures included mean airflow during voicing and number of breaths taken. The PAS captured phonatory aerodynamic functioning using a pneumotach coupled to a facemask, with external microphone. During speech, expired air flows through the pneumotach, which consists of a stainless-steel mesh screen with pressure transducers on either side. The system calculates the pressure difference across the screen to determine airflow rate. The microphone is positioned at the end of the pneumotach and internally calibrated per system specifications to represent a mouth-to-microphone distance of 15 cm. The participant sat with the facemask held snugly over their nose and mouth while they read the first fou
Measured: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Number of Breaths at Baseline and Follow up (5 Weeks)
Aerodynamic measurement: mean number of breaths in reading of a standard passage (The Rainbow Passage).
Measured: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Measured: Baseline (At initial therapy visit) and final follow up-visit (week 5)
Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Measured: Baseline (At initial therapy visit) and final follow up-visit (week 5)
Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
Aerodynamic measurement; mean duration to complete the reading of a standard passage (The Rainbow Passage).
Measured: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
Acoustic measurement: Cepstral Peak Prominence and its standard deviation while reading functional phrases.
Measured: At initial therapy visit (Baseline) and final follow up-visit (after week 5)
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Acoustic measurement: CPP F0 while reading functional phrases.
Measured: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
Aerodynamic measurement: mean F0 in reading of a standard passage (The Rainbow Passage).
Measured: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Vocal Intensity at Baseline and Follow up
Acoustic measurement: mean vocal intensity in dB SPL while reading functional phrases.
Measured: At initial therapy visit (baseline) and final follow up-visit (week 5)
Mean Change In Overall Voice Severity at 5 Weeks
Overall voice severity determined by Consensus Auditory Perceptual Evaluation - Voice (CAPE-V) score provided by blinded raters. The visual analog scale for overall voice severity used. Minimum score = 0, Maximum score = 100. Higher values indicate worse voice.
Measured: At initial therapy visit and final follow up-visit, after week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start20 Sep 2018
- Primary completion4 May 2020
- Study completion4 May 2020
Why it stopped: Due to the pandemic, recruitment ended earlier than expected and changes were required to alter data collection methods (and were approved by the IRB). Additional changes were also made to the protocol to move the study to an online platform.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Voice DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Gillespie, Emory University
- Investigators
- Amanda Gillespie, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696576
- Sponsor's protocol ID
- IRB00109224
- Other IDs
- PRO18040682
- Status last verified
- Aug 2021
- First submitted
- 20 Sep 2018
- Last updated
- 30 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: only de-identified data will be shared
Publications
Kost K, Parham K. Presbyphonia: What can be done? Ear Nose Throat J. 2017 Mar;96(3):108-110. doi: 10.1177/014556131709600309. No abstract available.
PubMed 28346640Polkey MI, Harris ML, Hughes PD, Hamnegard CH, Lyons D, Green M, Moxham J. The contractile properties of the elderly human diaphragm. Am J Respir Crit Care Med. 1997 May;155(5):1560-4. doi: 10.1164/ajrccm.155.5.9154857.
PubMed 9154857Janssens JP, Pache JC, Nicod LP. Physiological changes in respiratory function associated with ageing. Eur Respir J. 1999 Jan;13(1):197-205. doi: 10.1034/j.1399-3003.1999.13a36.x.
PubMed 10836348Skloot GS. The Effects of Aging on Lung Structure and Function. Clin Geriatr Med. 2017 Nov;33(4):447-457. doi: 10.1016/j.cger.2017.06.001. Epub 2017 Aug 19.
PubMed 28991643Thomas LB, Harrison AL, Stemple JC. Aging thyroarytenoid and limb skeletal muscle: lessons in contrast. J Voice. 2008 Jul;22(4):430-50. doi: 10.1016/j.jvoice.2006.11.006. Epub 2007 Jan 22.
PubMed 17241767Takano S, Kimura M, Nito T, Imagawa H, Sakakibara K, Tayama N. Clinical analysis of presbylarynx--vocal fold atrophy in elderly individuals. Auris Nasus Larynx. 2010 Aug;37(4):461-4. doi: 10.1016/j.anl.2009.11.013. Epub 2009 Dec 28.
PubMed 20036792Davids T, Klein AM, Johns MM 3rd. Current dysphonia trends in patients over the age of 65: is vocal atrophy becoming more prevalent? Laryngoscope. 2012 Feb;122(2):332-5. doi: 10.1002/lary.22397. Epub 2012 Jan 17.
PubMed 22252988Roy N, Stemple J, Merrill RM, Thomas L. Epidemiology of voice disorders in the elderly: preliminary findings. Laryngoscope. 2007 Apr;117(4):628-33. doi: 10.1097/MLG.0b013e3180306da1.
PubMed 17429872Golub 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 17087701Gregory ND, Chandran S, Lurie D, Sataloff RT. Voice disorders in the elderly. J Voice. 2012 Mar;26(2):254-8. doi: 10.1016/j.jvoice.2010.10.024. Epub 2011 May 6.
PubMed 21530163Palmer AD, Newsom JT, Rook KS. How does difficulty communicating affect the social relationships of older adults? An exploration using data from a national survey. J Commun Disord. 2016 Jul-Aug;62:131-46. doi: 10.1016/j.jcomdis.2016.06.002. Epub 2016 Jun 22.
PubMed 27420152Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
PubMed 20668659Marmor S, Horvath KJ, Lim KO, Misono S. Voice problems and depression among adults in the United States. Laryngoscope. 2016 Aug;126(8):1859-64. doi: 10.1002/lary.25819. Epub 2015 Dec 21.
PubMed 26691195Tay EY, Phyland DJ, Oates J. The effect of vocal function exercises on the voices of aging community choral singers. J Voice. 2012 Sep;26(5):672.e19-27. doi: 10.1016/j.jvoice.2011.12.014. Epub 2012 Jun 19.
PubMed 22717496Gorman S, Weinrich B, Lee L, Stemple JC. Aerodynamic changes as a result of vocal function exercises in elderly men. Laryngoscope. 2008 Oct;118(10):1900-3. doi: 10.1097/MLG.0b013e31817f9822.
PubMed 18622308
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy
- ClinicalTrials.gov ID
- NCT03696576
- Acronym / sponsor ID
- IRB00109224
- Conditions
- Voice Disorder, Vocal Cord Atrophy, Presbyphonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the pandemic, recruitment ended earlier than expected and changes were required to alter data collection methods (and were approved by the IRB). Additional changes were also made to the protocol to move the study to an online platform.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Posted 30 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The larynx and vocal folds undergo many age-related changes in their physiology and structure that can lead to undesirable effects on the voice, with changes in the respiratory system compounding these deficits. These changes, also called presbyphonia, can have serious detrimental effects on the lives of elderly individuals. There are few studies that have evaluated the use of voice therapy treatment options for these patients. The primary aim of this study is to test whether the addition of expiratory muscle strength training (EMST) to a current, validated voice therapy protocol aimed at treating presbyphonia, (phonation resistance training, PhoRTE) can improve outcomes of therapy.
Detailed description
The purpose of this study is to test whether the addition of EMST to PhoRTE Voice Therapy is at least as effective as PhoRTE alone for improving acoustic, aerodynamic, and patient-reported outcomes in patients affected by age-related vocal fold atrophy.
Voice therapy is often the first-line treatment for patients experiencing presbyphonia. Despite being the most common treatment for presbyphonia, scant literature exists on the efficacy of voice therapy for these patients. The current proposal aims to add to this growing body of literature. In general, studies of existing voice therapy programs for presbyphonia have demonstrated success in achieving improvement in aerodynamic (increased subglottal pressure), acoustic (increased shimmer, jitter, and decreased noise-to-harmonics ratio), and patient-centered outcomes (reduction in Voice Handicap Index scores, decreased phonatory effort). Ziegler et al. conducted a study comparing a standard voice therapy, Vocal Function Exercises (VFE) and Phonation Resistance Training Exercises (PhoRTE) and found that both therapies improved outcomes of voice-related quality of life, but only PhoRTE gave a statistically significant reduction in perceived phonatory effort. A specific therapy designed to address age-related changes to respiratory system is expiratory muscle strength training (EMST). EMST devices are loaded with a resistive spring which opens when a desired level of expiratory pressure is reached and maintained. Maintenance of consistent subglottal pressure is the foundation for phonation. EMST device training improves active expiratory muscle forces required for high-pressure activities such as long utterances or loud speech in vocally healthy individuals. When used in conjunction with traditional voice therapy, EMST use has also shown to increase maximum phonation time, maximum expiratory pressure, dynamic range, subglottal pressure, and perception of voice handicap in professional voice users over traditional voice therapy alone. The theoretical underpinnings for treatment of vocal fold atrophy with EMST are clear, as it addresses many of the common goals of treatment in patients with presbyphonia, but it has not yet been tested as a possible adjunctive treatment for patients undergoing voice therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PhoRTE | Active comparator | Behavioral: PhoRTEThis group will undergo standard PhoRTE therapy. |
| PhoRTE + EMST | Experimental | Device: EMST, Behavioral: PhoRTEThis group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 or older
- Diagnosis of presbyphonia (vocal fold atrophy) made by a fellowship-trained laryngologist and a voice specialized speech language pathologist
- Willingness to be randomized to one of two treatments
Key exclusion criteria (5 listed)
- Any concomitant laryngeal diagnoses or diseases known to affect voice function, including: amyloidosis, arytenoid dislocation, laryngeal cancer, cricoarytenoid fixation, vocal fold cyst(s), vocal nodules, vocal fold polyp(s), dysplasia, vocal fold fibrous mass(es), glottal web, vocal fold immobility, laryngeal stenosis, laryngocele, leukoplakia, Parkinson's disease, Reinke's edema, respiratory recurrent pneumonia, sarcoidosis, spasmodic dysphonia
- Any chronic lower airway disease such as chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, emphysema, cystic fibrosis
- History of acute stroke
- Untreated hypertension
- Untreated gastroesophageal reflux disease (GERD)
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 |
|---|---|---|
| EMSTTraining of the respiratory system muscles using the EMST device. | Device | PhoRTE + EMST |
| PhoRTECompleting of PhoRTE voice therapy. | Behavioural | PhoRTE, PhoRTE + EMST |
Primary outcome
Voice Handicap Index-10 (VHI-10) Score
Time frame: At each study visit through study completion; Time 0 (therapy visit 1-Baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)
The Voice Handicap Index-10 (VHI-10) is a validated assessment instrument that quantifies patient perceptions of his or her own voice handicap. A lower score on the VHI-10 indicates perception of a lesser voice handicap than a high score. Scores range from 0 to 40.
12 secondary outcomes
AVI Score at Baseline and Follow up (5 Weeks)
Time frame: At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)
Maximum Expiratory Pressure (MEP)
Time frame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Phonatory Airflow in Speech at Baseline and 5 Weeks
Time frame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Number of Breaths at Baseline and Follow up (5 Weeks)
Time frame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
Time frame: Baseline (At initial therapy visit) and final follow up-visit (week 5)
Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
Time frame: Baseline (At initial therapy visit) and final follow up-visit (week 5)
Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
Time frame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
Time frame: At initial therapy visit (Baseline) and final follow up-visit (after week 5)
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Time frame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
Time frame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Vocal Intensity at Baseline and Follow up
Time frame: At initial therapy visit (baseline) and final follow up-visit (week 5)
Mean Change In Overall Voice Severity at 5 Weeks
Time frame: At initial therapy visit and final follow up-visit, after week 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28346640Kost K, Parham K. Presbyphonia: What can be done? Ear Nose Throat J. 2017 Mar;96(3):108-110. doi: 10.1177/014556131709600309. No abstract available.
- Background: PubMed 9154857Polkey MI, Harris ML, Hughes PD, Hamnegard CH, Lyons D, Green M, Moxham J. The contractile properties of the elderly human diaphragm. Am J Respir Crit Care Med. 1997 May;155(5):1560-4. doi: 10.1164/ajrccm.155.5.9154857.
- Background: PubMed 10836348Janssens JP, Pache JC, Nicod LP. Physiological changes in respiratory function associated with ageing. Eur Respir J. 1999 Jan;13(1):197-205. doi: 10.1034/j.1399-3003.1999.13a36.x.
- Background: PubMed 28991643Skloot GS. The Effects of Aging on Lung Structure and Function. Clin Geriatr Med. 2017 Nov;33(4):447-457. doi: 10.1016/j.cger.2017.06.001. Epub 2017 Aug 19.
- Background: PubMed 17241767Thomas LB, Harrison AL, Stemple JC. Aging thyroarytenoid and limb skeletal muscle: lessons in contrast. J Voice. 2008 Jul;22(4):430-50. doi: 10.1016/j.jvoice.2006.11.006. Epub 2007 Jan 22.
- Background: PubMed 20036792Takano S, Kimura M, Nito T, Imagawa H, Sakakibara K, Tayama N. Clinical analysis of presbylarynx--vocal fold atrophy in elderly individuals. Auris Nasus Larynx. 2010 Aug;37(4):461-4. doi: 10.1016/j.anl.2009.11.013. Epub 2009 Dec 28.
- Background: PubMed 22252988Davids T, Klein AM, Johns MM 3rd. Current dysphonia trends in patients over the age of 65: is vocal atrophy becoming more prevalent? Laryngoscope. 2012 Feb;122(2):332-5. doi: 10.1002/lary.22397. Epub 2012 Jan 17.
- Background: PubMed 17429872Roy N, Stemple J, Merrill RM, Thomas L. Epidemiology of voice disorders in the elderly: preliminary findings. Laryngoscope. 2007 Apr;117(4):628-33. doi: 10.1097/MLG.0b013e3180306da1.
- Background: PubMed 17087701Golub 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.
- Background: PubMed 21530163Gregory ND, Chandran S, Lurie D, Sataloff RT. Voice disorders in the elderly. J Voice. 2012 Mar;26(2):254-8. doi: 10.1016/j.jvoice.2010.10.024. Epub 2011 May 6.
- Background: PubMed 27420152Palmer AD, Newsom JT, Rook KS. How does difficulty communicating affect the social relationships of older adults? An exploration using data from a national survey. J Commun Disord. 2016 Jul-Aug;62:131-46. doi: 10.1016/j.jcomdis.2016.06.002. Epub 2016 Jun 22.
- Background: PubMed 20668659Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
- Individual participant dataSharing planned: Yes. only de-identified data will be shared
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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. This study is not recruiting at the moment.
Amanda Gillespie principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMST and PhoRTE in people with Voice Disorder and Vocal Cord Atrophy, run by Emory University at 2 sites 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 5 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: stopped early, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 30 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice Handicap Index-10 (VHI-10) Score (time frame: At each study visit through study completion; Time 0 (therapy visit 1-Baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)). 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 NCT03696576, which also lists 35 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 30 Aug 2021.