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Exploring Breathing Patterns (EPISODE)

10. februar 2021 opdateret af: Cwm Taf University Health Board (NHS)

Exploring Patterns of Speech and Breathing to Indicate the Presence of Obstructive Disease

Study Title Exploring patterns of speech and breathing to indicate the presence of obstructive respiratory disease.

Study Design Prospective Case Control Study Study Participants Participants will be patients attending the respiratory physiology clinic at the Cardiopulmonary Unit, Prince Charles Hospital for an assessment of their lung function. In addition a cohort of control participants without obstructive respiratory disease will be recruited with the assistance of the British Lung Foundation charity.

Planned Size of Sample (if applicable) We have received funding for 52 ½ day sessions and we plan to recruit on average 2 participants per session. As such we aim to recruit a minimum of 100 participants. In addition we are working with the British Lung Foundation to recruit a smaller Cohort of control participants and aim to recruit a minimum of 25 control participants.

Planned Study Period Jan 2019 - Aug 2019 Research Aim(s) This primary objective of this novel study it to create an anonymised database of speech patterns of patients with chronic respiratory disease and healthy aged matched controls for comparison with lung function and medical history.

The primary aims are to:

  • Collect breathing patterns from individuals under a range of talking modalities
  • Understand how easy it is to gather short speech recordings
  • Explore the preferences of patients to be recorded talking

Studieoversigt

Status

Suspenderet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Wales
      • Abercynon, Wales, Det Forenede Kongerige, CF45 4SN
        • Cwm Taf Morgannwg Health Board

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patient >18 years old referred for spirometry in the Respiratory Physiology Clinic at Prince Charles Hospital;

Eligibility Criteria - Control Participants Control participants will be contact through the British Lung Foundations local groups who have indicated their willingness to be involved in local clinical research to act as control participants. As all prospective participants will have had their respiratory function measured before taking part by a Respiratory Physiologist, we do not expect to have to screen for medical issues for participation in the study. Furthermore, the actual tests the participants will be undertaking will be non - invasive, submaximal and will require little or no effort.

Beskrivelse

6.1.2 Inclusion criteria Patient Participants

  1. Adult patient >18 years old referred for spirometry in the Respiratory Physiology Clinic at Prince Charles Hospital;
  2. Clinically defined obstructive or restrictive respiratory disease (indicated by spirometry)
  3. Clinically stable (indicated by being able to undergo spirometry)
  4. No significant unstable disease co-morbidities (indicated by being able to undergo spirometry)
  5. Capable of providing informed consent.
  6. Willing to take part in all study measurements.
  7. The speaking exercise will be conducted in English on this study.
  8. Participants are not taking part in any other research. 6.1.3 Inclusion criteria Control Participants

1. No obstructive or restrictive respiratory disease (indicated by spirometry) 2. Clinically stable (indicated by being able to undergo spirometry) 3. No significant unstable disease co-morbidity's (indicated by being able to undergo spirometry) 4. Capable of providing informed consent. 5. Willing to take part in all study measurements. 6. The speaking exercise will be conducted in English on this study. 7. Participants are not taking part in any other research.

6.1.4 Exclusion criteria for both Patient and Control Participants

  1. Any form of challenge testing in the Respiratory Physiology Department involving salbutamol.
  2. Severe Sensory and/or Cognitive Impairment
  3. Inability to complete study measurements

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Collect breathing patterns from individuals under a range of talking modalities
Tidsramme: less than 5 minutes
breathing pattern
less than 5 minutes
Understand how easy it is to gather short speech recordings
Tidsramme: 3 minutes
verbal description
3 minutes
Explore the preferences of patients to be recorded talking
Tidsramme: 3 minutes
verbal description
3 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cwm Taf University Health Board (NHS)

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)

1. marts 2019

Primær færdiggørelse (Forventet)

1. marts 2022

Studieafslutning (Forventet)

1. marts 2022

Datoer for studieregistrering

Først indsendt

10. februar 2021

Først indsendt, der opfyldte QC-kriterier

10. februar 2021

Først opslået (Faktiske)

15. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 256266

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med KOL

Kliniske forsøg med Speech Recognition

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner