Preventing Dyspnea During Speech in Older Speakers
24. juni 2022 opdateret af: Maude Desjardins, University of Delaware
Self-Regulated Airflow Management in Daily Communicative Activities to Prevent 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- University of Delaware
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: All participants
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.
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Control condition: does not involve speech-related exercises
Experimental condition: involves speech-related exercises
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in reported dyspnea
Tidsramme: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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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.
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Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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Change in reported voice handicap
Tidsramme: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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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.
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Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in reported self-efficacy
Tidsramme: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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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.
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Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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Acceptability of the intervention
Tidsramme: Assessed after the 4-week experimental condition, at the end of the study period.
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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.
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Assessed after the 4-week experimental condition, at the end of the study period.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. september 2021
Primær færdiggørelse (Faktiske)
10. marts 2022
Studieafslutning (Faktiske)
10. marts 2022
Datoer for studieregistrering
Først indsendt
29. august 2021
Først indsendt, der opfyldte QC-kriterier
29. august 2021
Først opslået (Faktiske)
1. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2022
Sidst verificeret
1. juni 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1767412
Plan for individuelle deltagerdata (IPD)
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