Preventing Dyspnea During Speech in Older Speakers

Study Overview
=================
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).

Official Title
-----------------
Self-Regulated Airflow Management in Daily Communicative Activities to Prevent Dyspnea During Speech in Older Speakers

Conditions
-----------------
Dyspnea

Intervention / Treatment
-----------------
* Behavioral: Socialization phase
* Behavioral: Speech breathing intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>This is a single-arm trial. All participants will receive (1) a control condition (socialization phase, 2 weeks) and (2) an intervention condition (speech breathing intervention, 4 weeks). Group sessions will take place once a week, and participants will be instructed to practice their exercises every day at home during the study duration. | Behavioral: Socialization phase<br>* Control condition: does not involve speech-related exercises<br>Behavioral: Speech breathing intervention<br>* Experimental condition: involves speech-related exercises<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reported dyspnea | Participant self-ratings of dyspnea on the University of Cincinnati Dyspnea Questionnaire. This questionnaire contains 30 items scored on a Likert scale ranging from 1 (not at all short of breath) to 5 (always short of breath or cannot do). A higher scores indicates greater shortness of breath and therefore greater handicap. | Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition. | 
| Change in reported voice handicap | Participant self-ratings of voice handicap on the Voice Handicap Index-10. The Voice Handicap Index-10 is an ordinal scale that measures the degree of handicap a person experiences because of their voice disorder. Each item is scored on a Likert scale ranging from 0 to 4. The minimum score is 0 and the maximal score 40. A higher score indicates a greater perceived voice handicap. | Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reported self-efficacy | Participant self-ratings of self-efficacy for managing their symptoms, using the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Questionnaire - Managing Symptoms. This questionnaire contains 28 items, each scored on a Likert scale ranging from 1 (I am not at all confident) to 5 (I am very confident). A higher score indicates a greater self-efficacy. | Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition. | 
| Acceptability of the intervention | Participants' perceived acceptability of the intervention using the Acceptability of Intervention Measure. This questionnaire contains 5 items scored on a Likert scale ranging from 1 (completely disagree) to 5 (completely agree). A higher score indicates a greater acceptability. | Assessed after the 4-week experimental condition, at the end of the study period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aging, speech therapy, respiratory, dyspnea, communication, breathing, intervention, voice