Back to resultsPreventing Dyspnea During Speech in Older Speakers
Primary Purpose
Dyspnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Socialization phase
Speech breathing intervention
Sponsored by
About this trial
This is an interventional treatment trial for Dyspnea focused on measuring dyspnea, speech therapy, communication, aging, breathing, respiratory, intervention, voice
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.
Sites / Locations
- University of Delaware
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05029986
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
dyspnea, speech therapy, communication, aging, breathing, respiratory, intervention, voice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Socialization phase
Intervention Description
Control condition: does not involve speech-related exercises
Intervention Type
Behavioral
Intervention Name(s)
Speech breathing intervention
Intervention Description
Experimental condition: involves speech-related exercises
Primary Outcome Measure Information:
Title
Change in reported dyspnea
Description
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.
Time Frame
Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
Title
Change in reported voice handicap
Description
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.
Time Frame
Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
Secondary Outcome Measure Information:
Title
Change in reported self-efficacy
Description
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.
Time Frame
Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
Title
Acceptability of the intervention
Description
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.
Time Frame
Assessed after the 4-week experimental condition, at the end of the study period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Preventing Dyspnea During Speech in Older Speakers
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