Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID07160868

Open-label Randomized Controlled Trial Investigating the Relationship Between Obstructive Sleep Apnoea and Difficult Asthma

Led by St. James's Hospital, Ireland · Updated on 2026-05-26

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

St. James's Hospital, Ireland

Lead Sponsor

T

Tallaght University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on asthma control in adults with difficult-to-control asthma. This open-label, randomized controlled trial focuses on patients who have persistent asthma symptoms despite high-dose inhaler use and explores how OSA may contribute to their condition. The study aims to clarify the role of OSA in asthma management and examine whether treating OSA can improve asthma control, symptom burden, quality of life, and reduce exacerbations and healthcare use. Participants will undergo home-based sleep studies to detect OSA and then be assigned to one of three groups: asthma patients without OSA, asthma patients with OSA who do not receive treatment, and asthma patients with OSA who receive treatment using continuous positive airway pressure (CPAP) therapy at night. The treatment group will use the CPAP device to manage sleep apnoea while monitoring their asthma symptoms and lung function over the study period. Throughout the 3-4 month study, participants will track airflow variability using home electronic peak flow monitoring and report on asthma control and symptoms. Researchers will collect data on asthma exacerbations, lung function, airway inflammation, sleep quality, and healthcare utilization. The study includes regular assessments to evaluate the effects of CPAP treatment on asthma outcomes compared to untreated OSA and patients without OSA.

CONDITIONS

Brief Title

Obstructive Sleep Apnoea and Difficult Asthma (OSADA)

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have a clinical diagnosis of asthma supported by objective tests such as airway obstruction, bronchial hyper-responsiveness, or evidence of eosinophilic inflammation
  • Patients must be receiving step 4 or step 5 treatment according to the Global Initiative for Asthma (GINA) guidelines
  • Participants must be between 18 and 90 years old
Not Eligible

You will not qualify if you...

  • Patients who have had previous sleep study investigations
  • Patients with excessive daytime sleepiness, defined as an Epworth Sleepiness Score greater than 17
  • Patients with a previous diagnosis of any sleep disorder
  • Patients with resting low oxygen levels or those requiring long-term oxygen therapy
  • Patients unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo home sleep studies to determine the presence and severity of obstructive sleep apnoea (OSA).

1 home sleep study

Monitoring

Duration - 3 to 4 months

Participants are monitored for airflow variability, asthma control, lung function, and markers of airway inflammation over a 3- to 4-month period.

Regular home monitoring and assessments

Implementation

Duration - 3 to 4 months

Participants diagnosed with OSA and randomized to treatment receive continuous positive airway pressure (CPAP) therapy at night while continuing monitoring of asthma and respiratory measures.

Daily CPAP use with ongoing home monitoring

Trial Site Locations

Total: 1 location

1

St. James's Hospital

Dublin, Dublin, Ireland

Actively Recruiting

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Research Team

L

Laura Piggott, BM BS BSc MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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