Preventing Dyspnea During Speech in Older Speakers
24 juni 2022 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Delaware
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Newark, Delaware, Förenta staterna, 19713
- University of Delaware
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in reported dyspnea
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in reported self-efficacy
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 september 2021
Primärt slutförande (Faktisk)
10 mars 2022
Avslutad studie (Faktisk)
10 mars 2022
Studieregistreringsdatum
Först inskickad
29 augusti 2021
Först inskickad som uppfyllde QC-kriterierna
29 augusti 2021
Första postat (Faktisk)
1 september 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1767412
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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