Effekt av CPAP-behandling hos pasienter med alvorlig ukontrollert astma: ASTHMA-SLEEP-forsøket
Effekt av CPAP-behandling på astmakontroll hos pasienter med alvorlig ukontrollert astma og obstruktiv søvnapné: ASTHMA-SLEEP-forsøket
The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Background: The prevalence of obstructive sleep apnea (OSA) is high in patients with severe uncontrolled asthma and can worsen asthma control. Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma. Nevertheless, there are no studies in patients with severe uncontrolled asthma.
Primary objective: To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and OSA.
Methodology: Multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (Epworth sleepiness scale score ≤10). All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (AHI) ≥15/hour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus CPAP. Monitoring will be carried out during12 months. Patients will be evaluated at inclusion, at 1 month, 6 and 12 months.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mireia Dalmases, MD
- Telefonnummer: +34932275746
- E-post: mdalmase@clinic.cat
Studiesteder
-
-
Spain
-
Barcelona, Spain, Spania, 08036
- Rekruttering
- Hospital Clinic Barcelona
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age >18 years
- Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study.
- Apnea hypopnea rate greater than or equal to 15/hour
- Punctuation in the Epworth Sleepiness Scale ≤10
- Obtaining informed consent.
Exclusion Criteria:
- Previous treatment with CPAP
- Patient with central sleep apnea or Cheyne-Stokes respiration
- Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,
- Resistant hypertension
- Active Smoking
- Unstable comorbidities or medications may interfere with asthma control
- Pregnancy
- Any process that reduces life expectancy to <1 year,
- Any medical or social factor that may limit CPAP compliance
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Conservative treatment
Subjects allocated to this arm will receive hygienic and dietary measures counselling |
Subjects allocated to this arm will receive hygienic and dietary counselling |
|
Eksperimentell: CPAP treatment
Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP) |
Subjects allocated to this arm will receive continuous positive airway pressure (CPAP) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma control questionnaire
Tidsramme: 12 months
|
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ) |
12 months
|
|
Asthma control test
Tidsramme: 12 months
|
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT) |
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lung function- forced expiratory volume in the first second (FEV1) in spirometry
Tidsramme: 12 months
|
To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry |
12 months
|
|
Lung function-forced vital capacity (FVC) in spriometry
Tidsramme: 12 months
|
To evaluate the impact of CPAP treatment on FVC (ml) on spirometry |
12 months
|
|
Prevalence of OSA in severe uncontrolled asthma
Tidsramme: Baseline
|
Determine the prevalence of OSA in patients with severe uncontrolled asthma |
Baseline
|
|
Inflammatory profile
Tidsramme: Baseline, 6 and 12 months
|
Plasma proteins from peripheral blood samples will be used to analyze an inflammatory panel using a high-throughput, multiplex immunoassay technology based on Proximity Extension Assays (PEA) at baseline and after CPAP treatment |
Baseline, 6 and 12 months
|
|
Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)
Tidsramme: 12 months
|
Study whether OSA ans its treatment affects quality of life in subjects with severe uncontrolled asthma based on the punctuation obtained in the mini-AQLQ questionnaire. Higher scores indicate better quality of life |
12 months
|
|
Exacerbations
Tidsramme: From enrollment to the end of the study at 12 months
|
Number of excarbations the year before starting the study and at 12-month of treatment in both arms |
From enrollment to the end of the study at 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mireia Dalmases, MD, Hospital Clinic
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Sykdommer i immunsystemet
- Sykdommer i luftveiene
- Lungesykdommer
- Respirasjonsforstyrrelser
- Bronkiale sykdommer
- Lungesykdommer, obstruktiv
- Respiratorisk overfølsomhet
- Overfølsomhet, Umiddelbar
- Overfølsomhet
- Søvnvåkenforstyrrelser
- Apné
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnapné syndromer
- Astma
- Søvnapné, obstruktiv
- Helsevesenets kvalitet, tilgang og evaluering
- Undersøkelsesteknikker
- Epidemiologiske metoder
- Terapeutikk
- Datainnsamling
- Helsevesenets evalueringsmekanismer
- Kvalitet på helsehjelpen
- Folkehelse
- Miljø og folkehelse
- Epidemiologiske målinger
- Airway Management
- Åndedrettsbehandling
- Positiv trykk respirasjon
- Respirasjon, kunstig
- Kontinuerlig positivt luftveistrykk
- Ernæringsvurdering
Andre studie-ID-numre
- HCB/2022/1204
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Anonymized IPD will be available upon reasonable request following publication of the study results. Requests will be valuated by the study team and be subject to applicable ethical, legal and data portection requeriments.
IPD-delingstidsramme
IPD will be available upon reasonable request following publication of the study results.
Tilgangskriterier for IPD-deling
Access will be granted to qualified researchers for cientifically valid reserach purposes
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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