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NCT Number: NCT05029986

Preventing Dyspnea During Speech in Older Speakers

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).

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Socialization phase

Behavioral

Control condition: does not involve speech-related exercises

Speech breathing intervention

Behavioral

Experimental condition: involves speech-related exercises

Primary outcomes

  1. Change in reported dyspnea

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

    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.

  2. Change in reported voice handicap

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

    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 outcomes

  1. Change in reported self-efficacy

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

    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.

  2. Acceptability of the intervention

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

    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.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2021
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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