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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05029986
Other study ID # 1767412
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date March 10, 2022

Study information

Verified date June 2022
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 10, 2022
Est. primary completion date March 10, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Socialization phase
Control condition: does not involve speech-related exercises
Speech breathing intervention
Experimental condition: involves speech-related exercises

Locations

Country Name City State
United States University of Delaware Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 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.
Secondary 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.
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