NCT06314477

Brief Summary

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 27, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

February 25, 2024

Last Update Submit

December 4, 2025

Conditions

AsthmaObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Asthma control questionnaire

    To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)

    12 months

  • Asthma control test

    To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)

    12 months

Secondary Outcomes (5)

  • Lung function- forced expiratory volume in the first second (FEV1) in spirometry

    12 months

  • Lung function-forced vital capacity (FVC) in spriometry

    12 months

  • Prevalence of OSA in severe uncontrolled asthma

    Baseline

  • Inflammatory profile

    Baseline and 12 months

  • Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)

    12 months

Study Arms (2)

Conservative treatment

ACTIVE COMPARATOR

Subjects allocated to this arm will receive hygienic and dietary measures counselling

Other: Hygienic and dietary advice

CPAP treatment

EXPERIMENTAL

Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP)

Device: CPAP treatment

Interventions

Hygienic and dietary adviceOTHER

Subjects allocated to this arm will receive hygienic and dietary counselling

Conservative treatment
CPAP treatmentDEVICE

Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)

CPAP treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Apnea hypopnea rate greater than or equal to 15/hour
  • Punctuation in the Epworth Sleepiness Scale ≤10
  • Obtaining informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Spain, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAsthma

Interventions

Continuous Positive Airway PressureNutrition Assessment

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory TherapyData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Mireia Dalmases, MD

    Hospital Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireia Dalmases, MD

CONTACT

+34932275746mdalmase@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 25, 2024

First Posted

March 18, 2024

Study Start

December 27, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations

ES(1)