Clinical trial NCT03557775: Respiratory Muscle Strength Training in Presbyphonia
Official title: Respiratory Muscle Strength Training in Presbyphonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbylarynx
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Presbyphonia is an age-related voice disorder that affects more than 10 million people in the United States. Presbyphonia is characterized by vocal fold atrophy that impairs older individuals' ability to communicate, leading to social isolation and reduced quality of life. Outcomes from current treatment approaches are often suboptimal for patients with presbyphonia as they do not sufficiently challenge the respiratory system to induce meaningful change. It is highly likely that the addition of respiratory training would result in greatly improved outcomes, such as the ability to speak loud and long enough to have a normal conversation. The purpose of this study will be to examine the effect of adding inspiratory muscle strength training (IMST) or expiratory muscle strength training (EMST) to standard of care voice therapy on respiratory and voice outcomes in patients with an age-related voice disorder.

Forty-eight participants diagnosed with presbyphonia will be blocked-randomized into three intervention groups, using a 3-parallel arm design: IMST and voice exercises, EMST and voice exercises, and voice exercises during all session. Study endpoints will be the change in voice and respiratory measures after four treatment sessions compared to baseline values. Response to treatment will be analyzed to determine if there are subgroups of high- or low-responders based on baseline voice and respiratory characteristics.


Eligibility criteria: Inclusion Criteria:

* must receive a diagnosis of presbyphonia by a trained laryngologist. The diagnosis will be given following a visual examination if the observations are consistent with the characteristics of a presbylarynx, as judged by the laryngologist.
* must be 50 years old and older.

Exclusion Criteria:

* has received voice therapy in the past year
* presents with a vocal fold pathology other than presbyphonia
* has a known neurologic or a progressive neuromuscular disease
* has a medical condition that could be aggravated by the experimental intervention, or any condition judged by the physician (Dr. Halstead) as being unsuitable for RMST.
* has dysarthria or a language disorder
* has a hearing loss that is not adequately managed
* has a cognitive disorder that might affect treatment compliance
* is unable to give informed consent

Primary outcomes:
measure: Post-Treatment Mean in Voice Handicap Index Score
timeFrame: up to 5 weeks after baseline
Secondary outcomes:
measure: Post-treatment Mean in (Habitual) Sound Pressure Level
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)
timeFrame: up to 5 weeks after baseline
measure: Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Overall Severity of Voice Quality
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Baseline Bowing Index
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Glottal Function Index (GFI) Score
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Average Glottal Airflow
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Average Subglottal Pressure
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Aerodynamic Resistance
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Maximum Expiratory Pressure (MEP)
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Maximum Inspiratory Pressure (MIP)
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Forced Vital Capacity (FVC)
timeFrame: up to 5 weeks after baseline
measure: Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: up to 5 weeks after baseline
measure: Post-Treatment Mean for FEV1/FVC
timeFrame: up to 5 weeks after baseline
Other outcomes:
measure: Voice-Vibratory Assessment With Laryngeal Imaging
timeFrame: up to 5 weeks after baseline
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Heather Bonilha, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Maude Desjardins, M.Sc.
role: STUDY_DIRECTOR
References: