Treating obstructive sleep apnoea in people with difficult-to-control asthma
Open-label Randomized Controlled Trial Investigating the Relationship Between Obstructive Sleep Apnoea and Difficult Asthma
NA · St. James's Hospital, Ireland · NCT07160868
We will see if treating obstructive sleep apnoea with CPAP helps adults with difficult-to-control asthma improve their symptoms, asthma control, and quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | St. James's Hospital, Ireland (other) |
| Locations | 1 site (Dublin, Dublin) |
| Trial ID | NCT07160868 on ClinicalTrials.gov |
What this trial studies
This is an open-label, randomized controlled trial enrolling adults with difficult-to-control asthma who undergo home sleep testing for obstructive sleep apnoea (OSA). Participants found to have OSA are randomized to CPAP treatment or no CPAP, while those without OSA form a reference group. The study will compare asthma control, symptom burden, and quality of life as primary outcomes, with secondary outcomes including exacerbation rates, sleep quality, and healthcare use. Participants are recruited from Difficult Asthma clinics and must be on GINA step 4–5 therapy and meet other eligibility criteria.
Who should consider this trial
Good fit: Adults aged 18–90 with difficult-to-control asthma on GINA step 4–5 therapy who have not had prior sleep studies and can give informed consent are the ideal candidates.
Not a fit: Patients without OSA, those with prior sleep study or established sleep disorder, those with excessive daytime sleepiness (ESS >17), or resting hypoxaemia are unlikely to benefit from CPAP within this protocol.
Why it matters
Potential benefit: If successful, diagnosing and treating OSA could improve asthma control, reduce symptoms and exacerbations, and lower healthcare use for people with difficult-to-control asthma.
How similar studies have performed: Some observational studies suggest treating OSA can help asthma outcomes, but randomized evidence is limited and this randomized open-label approach is relatively novel in difficult asthma cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dublin, Dublin
- St. James's Hospital — Dublin, Dublin, Ireland (RECRUITING)
Study contacts
- Study coordinator: Laura Piggott, BM BS BSc MSc
- Email: laurampiggott@gmail.com
- Phone: +353876801786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma, OSA - Obstructive Sleep Apnea, CPAP Treatment