Clinical trial NCT05029986: Preventing Dyspnea During Speech in Older Speakers
Official title: Self-Regulated Airflow Management in Daily Communicative Activities to Prevent Dyspnea During Speech in Older Speakers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Keywords: dyspnea
speech therapy
communication
aging
breathing
respiratory
intervention
voice
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Due to various comorbidities affecting the respiratory system, older speakers are at risk of experiencing breathing discomfort (dyspnea) during high-demand vocal activities such as singing, loud speaking, and speaking while exercising. Dyspnea during speech can promote avoidance of certain situations involving voice production, thus leading to vocal deconditioning and decreased quality of life. The goal of this pilot study is to test the feasibility and acceptability of a 4-week remote group intervention targeting phonatory dyspnea, and to gather preliminary efficacy data.

Participants will receive an intervention including a 2-week socialization phase (control condition) and a 4-week speech breathing intervention phase (experimental condition). Both phases will be delivered remotely and in a group setting (10 participants per group).


Eligibility criteria: Inclusion Criteria:

* sign the informed consent form
* report dyspnea in at least one of the items of the University of Cincinnati Dyspnea Questionnaire referring to speech
* be available during the dates of the scheduled group interventions
* be aged 50 years or older

Exclusion Criteria:

* do not have access to a computer and internet connection
* present with a known voice pathology (other than age-related vocal fold atrophy) and/or are receiving speech therapy at the time of the study
* have a known neurodegenerative disease affecting speech/voice
* are a current smoker
* are receiving pulmonary rehabilitation at the time of the study or are starting a new medication regimen for a respiratory disease at the time of study onset;
* have a hearing loss that is not adequately managed, as judged by the Principal Investigator (PI)
* have professional vocal training \[amateur choir singers will not be excluded\]
* cannot provide informed consent or easily follow instructions
* have any other condition that precludes them from participating in the behavioral interventions, as judged by the PI.

Primary outcomes:
measure: Change in reported dyspnea
timeFrame: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
measure: Change in reported voice handicap
timeFrame: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
Secondary outcomes:
measure: Change in reported self-efficacy
timeFrame: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
measure: Acceptability of the intervention
timeFrame: Assessed after the 4-week experimental condition, at the end of the study period.
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References: