RecruitingNot ApplicableNCT07160868

Obstructive Sleep Apnoea and Difficult Asthma (OSADA)

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

Sponsor

St. James's Hospital, Ireland

Enrollment

80 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Asthma (Diagnosis)OSA - Obstructive Sleep Apnea CPAP Treatment

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how many people with difficult-to-control (severe) asthma also have undiagnosed obstructive sleep apnea (OSA) — a condition where breathing repeatedly stops during sleep. Researchers believe untreated sleep apnea may be making asthma harder to control, and identifying it could improve treatment. **You may be eligible if...** - You are between 18 and 90 years old - You have a confirmed clinical diagnosis of asthma with supporting objective tests - Your asthma requires Step 4 or Step 5 treatment (meaning it is severe and not fully controlled on high-dose therapy) **You may NOT be eligible if...** - You have already had a sleep study - You already have a diagnosed sleep disorder - You have excessive daytime sleepiness (ESS score above 17) - You require long-term supplemental oxygen due to low resting oxygen levels - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous positive airway pressure (CPAP)

Continuous positive airway pressure - device to be used at night in the treatment of sleep apnoea

Locations(1)

St. James's Hospital

Dublin, Dublin, Ireland

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NCT07160868

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