Preventing Dyspnea During Speech in Older Speakers

NCT05029986 | Completed

• 1 other identifier: 1767412
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Dyspnea

Keywords

dyspnea; speech therapy; communication; aging; breathing; respiratory; intervention; voice

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in reported self-efficacy

  Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.

• Acceptability of the intervention

  Assessed after the 4-week experimental condition, at the end of the study period.

Study Arms (1)

All participants

EXPERIMENTAL

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; Behavioral: Speech breathing intervention

Interventions

Socialization phase BEHAVIORAL

Control condition: does not involve speech-related exercises

All participants

Speech breathing intervention BEHAVIORAL

Experimental condition: involves speech-related exercises

All participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Dyspnea; Communication Disorders; Communication; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Behavior; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral researcher

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 1, 2021
• Study Start: September 15, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)