Obstructive Sleep Apnoea and Difficult Asthma (OSADA)

Recruiting · NCT07160868 · Interventional (participants receive a specific treatment) · Lead sponsor: St. James's Hospital, Ireland

View the official record on ClinicalTrials.gov →

Asthma

Interventions studied

Continuous positive airway pressure (CPAP)

What this trial is about

The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma. Participants will undergo home-based sleep studies to assess for OSA and are then allocated to one of three arms: 1) Patients with OSA treated with CPAP (intervention group), 2) Patients with OSA not treated for OSA (control group) and 3) Patients without OSA (reference group). The primary objective is to evaluate whether treating OSA improves asthma control, symptom burden, and quality of life compared to untreated OSA and to patients without OSA. Secondary outcomes include exacerbation rates, sleep quality, and healthcare utilization. This trial aims to clarify the contribution of OSA to poor asthma control and the potential benefits of integrated sleep and respiratory care in this complex population.

Who can take part

Age range

18 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Patients must have a clinical diagnosis of asthma with supportive objective diagnostics including but not limited to, variable airflow obstruction, bronchial-hyper responsiveness and demonstrable eosinophilic inflammation via fractional exhaled nitric oxide or peripheral eosinophilia
Patients receiving step 4 or step 5 of 'The Global Initiative for Asthma' (GINA) treatment guidelines will be selected
Between the ages of 18 to 90 years of age

Exclusion criteria

Patients with previous sleep study investigations
Excessive daytime sleepiness; ESS \>17
Previous diagnosis of a sleep disorder
Resting hypoxaemia or need for long-term oxygen therapy
Inability to provide informed consent

Where it is running

1 location listed.

St. James's Hospital - Dublin, Dublin, Ireland

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →