TerminatedNCT03696576Updated Aug 30, 2021Results posted

Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy

An interventional study of EMST and PhoRTE in Voice Disorder, Vocal Cord Atrophy and Presbyphonia, sponsored by Emory University. Terminated at 2 sites in United States. Open to participants aged 65 Years to 95 Years. Per ClinicalTrials.gov, last updated 2021-08-30.

Sponsored by Emory University · Not applicable, Interventional, and Treatment

Why this study was terminated

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.

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 65 Years to 95 Years
Sex: All

Study 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. 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 studied

Voice Disorder
Vocal Cord Atrophy
Presbyphonia

Browse trials for

Voice Disorders 77

In context

Voice Disorders

77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.

This study's enrollment of 24 is below the median of 41 across 54 interventional studies indexed under Voice Disorders.

Browse Voice Disorders studies →

Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.

Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.

Browse Emory University studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years to 95 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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 (COPD), asthma, chronic bronchitis, emphysema, cystic fibrosis
History of acute stroke
Untreated hypertension
Untreated gastroesophageal reflux disease (GERD)

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD: Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Care provider)
Enrollment: 24 participants (actual)

Study arms

Active comparator
PhoRTE
This group will undergo standard PhoRTE therapy.
Behavioral: PhoRTE
Experimental
PhoRTE + EMST
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
Device: EMST · Behavioral: PhoRTE

Interventions

DeviceEMST
Training of the respiratory system muscles using the EMST device.
BehavioralPhoRTE
Completing of PhoRTE voice therapy.

What researchers measure

Primary outcomes

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.
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)

Secondary outcomes

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.
Time frame: 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.
Time frame: 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
Time frame: 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).
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
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.
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
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.
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)
Aerodynamic measurement; mean duration to complete the reading of a standard passage (The Rainbow Passage).
Time frame: 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.
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)
Acoustic measurement: CPP F0 while reading functional phrases.
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
Aerodynamic measurement: mean F0 in reading of a standard passage (The Rainbow Passage).
Time frame: 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.
Time frame: 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.
Time frame: At initial therapy visit and final follow up-visit, after week 5

Results

Posted Aug 30, 2021

Participant flow

Participants were recruited for the study from September 2018 until March 2020.

Participant flow — Overall Study
Milestone	PhoRTE	PhoRTE + EMST
Started	13	11
Completed	10	6
Not completed	3	5
Withdrew: Soreness of throat after therapy	1	1
Withdrew: Lost to follow-up	2	4

Outcome measures

PrimaryVoice 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.

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)
Reported as:: Mean · score on a scale

Voice Handicap Index-10 (VHI-10) Score
score on a scale	PhoRTE	PhoRTE + EMST
Baseline	15.80 ± 6.94	17.45 ± 8.55
Follow up-week 1	18.85 ± 9.5	20.54 ± 10.53
Follow up-week 2	17.00 ± 9.86	17.00 ± 12.22
Follow up-week 3	14.09 ± 9.76	15.67 ± 11.94
Follow up-week 4	12.00 ± 11.07	10.17 ± 6.97
Follow up-week 5	13.3 ± 10.86	10.50 ± 9.69

SecondaryAVI 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.

Time frame:: At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)
Reported as:: Mean · score on a scale

AVI Score at Baseline and Follow up (5 Weeks)
score on a scale	PhoRTE	PhoRTE + EMST
Baseline	41.54 ± 6.19	43.64 ± 6.73
Follow Up	23.13 ± 6.72	27.36 ± 8.23

SecondaryMaximum 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.

Time frame:: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Reported as:: Mean · cm H2O

Maximum Expiratory Pressure (MEP)
cm H2O	PhoRTE	PhoRTE + EMST
Baseline	43.08 ± 7.85	49.18 ± 8.20
Follow Up	51.32 ± 8.83	81.81 ± 9.94

SecondaryPhonatory 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

Time frame:: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Reported as:: Mean · Liters/second

Phonatory Airflow in Speech at Baseline and 5 Weeks
Liters/second	PhoRTE	PhoRTE + EMST
Baseline	0.29 ± 0.05	0.18 ± 0.06
Follow Up	0.13 ± 0.07	0.12 ± 0.08

SecondaryNumber of Breaths at Baseline and Follow up (5 Weeks)

Aerodynamic measurement: mean number of breaths in reading of a standard passage (The Rainbow Passage).

Time frame:: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Reported as:: Mean · number of breaths

Number of Breaths at Baseline and Follow up (5 Weeks)
number of breaths	PhoRTE	PhoRTE + EMST
Baseline	7.17 ± 0.96	6.59 ± 1.13
Follow Up	7.36 ± 1	5.52 ± 1.29

SecondaryMean 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.

Time frame:: Baseline (At initial therapy visit) and final follow up-visit (week 5)
Reported as:: Mean · score on a scale

Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
score on a scale	PhoRTE	PhoRTE + EMST
Baseline	26.05 ± 7.15	28.85 ± 7.84
Follow Up	12.08 ± 8.57	20.7 ± 9.94

SecondaryCepstral 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)
Reported as:: Mean · score on a scale

Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
score on a scale	PhoRTE	PhoRTE + EMST
Baseline	33.93 ± 8.02	42.9 ± 8.79
Follow Up	13.08 ± 10.39	41.56 ± 12.27

SecondaryDuration 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).

Time frame:: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Reported as:: Mean · seconds

Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
seconds	PhoRTE	PhoRTE + EMST
Baseline	27.23 ± 1.54	28.56 ± 1.61
Follow up	25.31 ± 1.84	24.93 ± 2.11

SecondaryCepstral Peak Prominence at Baseline and 5 Weeks Follow up

Acoustic measurement: Cepstral Peak Prominence and its standard deviation while reading functional phrases.

Time frame:: At initial therapy visit (Baseline) and final follow up-visit (after week 5)
Reported as:: Mean · dB

Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
dB	PhoRTE	PhoRTE + EMST
Baseline	8.05 ± 0.98	7.13 ± 1.07
Follow Up	11.32 ± 1.27	7.68 ± 1.50

SecondaryCepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)

Acoustic measurement: CPP F0 while reading functional phrases.

Time frame:: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Reported as:: Mean · Hz

Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Hz	PhoRTE	PhoRTE + EMST
Baseline	166.21 ± 14.51	167.04 ± 15.9
Follow Up	160.97 ± 15.81	178.09 ± 17.86

SecondaryMean Fundamental Frequency in Sentence at Baseline and at 5 Weeks

Aerodynamic measurement: mean F0 in reading of a standard passage (The Rainbow Passage).

Time frame:: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Reported as:: Mean · Hz

Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
Hz	PhoRTE	PhoRTE + EMST
Baseline	166.31 ± 8.66	152.78 ± 9.04
Follow Up	177.09 ± 10.15	156.81 ± 11.55

SecondaryVocal Intensity at Baseline and Follow up

Acoustic measurement: mean vocal intensity in dB SPL while reading functional phrases.

Time frame:: At initial therapy visit (baseline) and final follow up-visit (week 5)
Reported as:: Mean · dB SPL

Vocal Intensity at Baseline and Follow up
dB SPL	PhoRTE	PhoRTE + EMST
Baseline	74.22 ± 1.49	76.48 ± 1.56
Follow Up	78.06 ± 1.95	73.56 ± 2.31

SecondaryMean 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.

Time frame:: At initial therapy visit and final follow up-visit, after week 5

No measurements were reported for this outcome.

Adverse events

Collected over 5 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PhoRTE	0/13 (0%)	0/13 (0%)	0/13 (0%)
PhoRTE + EMST	0/11 (0%)	0/11 (0%)	0/11 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	PhoRTE	PhoRTE + EMST	Total
Mean	72.10 ± 7.91	75.22 ± 8.12	73.53 ± 7.99

Sex: Female, Male
Sex: Female, Male(Participants)	PhoRTE	PhoRTE + EMST	Total
Female	9	6	15
Male	4	5	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	PhoRTE	PhoRTE + EMST	Total
Hispanic or Latino	1	0	1
Not Hispanic or Latino	11	11	22
Unknown or Not Reported	1	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	PhoRTE	PhoRTE + EMST	Total
American Indian or Alaska Native	0	0	0
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	3	6
White	8	7	15
More than one race	1	0	1
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	PhoRTE	PhoRTE + EMST	Total
United States	13	11	24

Study locations

2 sites

Emory University Hospital Midtown
Atlanta, Georgia 30308, United States
University of Pittsburgh Voice Center
Pittsburgh, Pennsylvania 15219, United States

References and documents

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 28346640 ↗
Polkey 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 9154857 ↗
Janssens 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 10836348 ↗
Skloot 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 28991643 ↗
Thomas 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 17241767 ↗
Takano 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 20036792 ↗
Davids 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 22252988 ↗
Roy 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 17429872 ↗
Golub 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 ↗
Gregory 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 21530163 ↗
Palmer 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 27420152 ↗
Holt-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 20668659 ↗
Marmor 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 26691195 ↗
Tay 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 22717496 ↗
Gorman 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 ↗
Ziegler A, Verdolini Abbott K, Johns M, Klein A, Hapner ER. Preliminary data on two voice therapy interventions in the treatment of presbyphonia. Laryngoscope. 2014 Aug;124(8):1869-76. doi: 10.1002/lary.24548. Epub 2014 Jan 29. PubMed 24375313 ↗
Caskey CI, Zerhouni EA, Fishman EK, Rahmouni AD. Aging of the diaphragm: a CT study. Radiology. 1989 May;171(2):385-9. doi: 10.1148/radiology.171.2.2704802. PubMed 2704802 ↗
Kim J, Sapienza CM. Implications of expiratory muscle strength training for rehabilitation of the elderly: Tutorial. J Rehabil Res Dev. 2005 Mar-Apr;42(2):211-24. doi: 10.1682/jrrd.2004.07.0077. PubMed 15944886 ↗
Enright PL, Kronmal RA, Higgins MW, Schenker MB, Haponik EF. Prevalence and correlates of respiratory symptoms and disease in the elderly. Cardiovascular Health Study. Chest. 1994 Sep;106(3):827-34. doi: 10.1378/chest.106.3.827. PubMed 8082366 ↗
Nam DH, Lim JY, Ahn CM, Choi HS. Specially programmed respiratory muscle training for singers by using respiratory muscle training device (Ultrabreathe). Yonsei Med J. 2004 Oct 31;45(5):810-7. doi: 10.3349/ymj.2004.45.5.810. PubMed 15515190 ↗
Wingate JM, Brown WS, Shrivastav R, Davenport P, Sapienza CM. Treatment outcomes for professional voice users. J Voice. 2007 Jul;21(4):433-49. doi: 10.1016/j.jvoice.2006.01.001. Epub 2006 Apr 3. PubMed 16581229 ↗
Baker S, Davenport P, Sapienza C. Examination of strength training and detraining effects in expiratory muscles. J Speech Lang Hear Res. 2005 Dec;48(6):1325-33. doi: 10.1044/1092-4388(2005/092). PubMed 16478374 ↗
Sapienza CM, Wheeler K. Respiratory muscle strength training: functional outcomes versus plasticity. Semin Speech Lang. 2006 Nov;27(4):236-44. doi: 10.1055/s-2006-955114. PubMed 17117350 ↗
Murry T. Subglottal pressure and airflow measures during vocal fry phonation. J Speech Hear Res. 1971 Sep;14(3):544-51. doi: 10.1044/jshr.1403.544. No abstract available. PubMed 5163888 ↗
Smitheran JR, Hixon TJ. A clinical method for estimating laryngeal airway resistance during vowel production. J Speech Hear Disord. 1981 May;46(2):138-46. doi: 10.1044/jshd.4602.138. PubMed 7253590 ↗
Laciuga H, Rosenbek JC, Davenport PW, Sapienza CM. Functional outcomes associated with expiratory muscle strength training: narrative review. J Rehabil Res Dev. 2014;51(4):535-46. doi: 10.1682/JRRD.2013.03.0076. PubMed 25144167 ↗
Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009. PubMed 15475780 ↗
Gillespie AI, Dastolfo C, Magid N, Gartner-Schmidt J. Acoustic analysis of four common voice diagnoses: moving toward disorder-specific assessment. J Voice. 2014 Sep;28(5):582-8. doi: 10.1016/j.jvoice.2014.02.002. Epub 2014 May 28. PubMed 24880672 ↗
Awan SN, Roy N, Jette ME, Meltzner GS, Hillman RE. Quantifying dysphonia severity using a spectral/cepstral-based acoustic index: Comparisons with auditory-perceptual judgements from the CAPE-V. Clin Linguist Phon. 2010 Sep;24(9):742-58. doi: 10.3109/02699206.2010.492446. PubMed 20687828 ↗
Kempster GB, Gerratt BR, Verdolini Abbott K, Barkmeier-Kraemer J, Hillman RE. Consensus auditory-perceptual evaluation of voice: development of a standardized clinical protocol. Am J Speech Lang Pathol. 2009 May;18(2):124-32. doi: 10.1044/1058-0360(2008/08-0017). Epub 2008 Oct 16. PubMed 18930908 ↗
Etter 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 29748025 ↗
Gartner-Schmidt J, Rosen C. Treatment success for age-related vocal fold atrophy. Laryngoscope. 2011 Mar;121(3):585-9. doi: 10.1002/lary.21122. Epub 2010 Aug 3. PubMed 21344441 ↗
Sauder C, Roy N, Tanner K, Houtz DR, Smith ME. Vocal function exercises for presbylaryngis: a multidimensional assessment of treatment outcomes. Ann Otol Rhinol Laryngol. 2010 Jul;119(7):460-7. doi: 10.1177/000348941011900706. PubMed 20734967 ↗
Fairbanks G. Voice and articulation drill book. 2nd ed. New York: Harper and Row; 1960.
Statistics FIFoAR. Older Americans 2010: Key Indicators of Well-Being. US Government Printing Office. 2010.

Study documents

Protocol and statistical analysis plan ↗ · Aug 5, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — only de-identified data will be shared

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: during and through data analysis

Access criteria: additional researchers may receive de-identified information only if a data use agreement has been executed.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2018 to primary completion in May 2020, 19 months.

Results were first posted in Aug 2021, 1 year 3 months after primary completion. A results delay was requested in Jun 2021.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 20, 2018
First posted: Oct 4, 2018
StartActual: Sep 20, 2018
Primary completionActual: May 4, 2020
CompletionActual: May 4, 2020
Results delay requested: Jun 17, 2021
Results first posted: Aug 30, 2021
Last update: Aug 30, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03696576
Lead sponsor: Emory University
Responsible party: Amanda Gillespie (Assitant professor, Emory University) — Principal investigator
First posted: Oct 4, 2018
Start date: Sep 20, 2018
Primary completion: May 4, 2020
Completion: May 4, 2020
Results posted: Aug 30, 2021
Last update: Aug 30, 2021

Study contacts

Amanda Gillespie

principal investigator · Emory University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Voice Disorders →

Other studies from this sponsor

Emory University →

Start the discussion