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Obstructive Sleep Apnoea and Difficult Asthma (OSADA)

ConditionsAsthma (Diagnosis)OSA - Obstructive Sleep ApneaCPAP Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSt. James's Hospital, Ireland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous positive airway pressure (CPAP)

    Device

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

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Asthma - no sleep apnoeaNo intervention 0 interventions
Group B: Asthma - sleep apnoea, no treatmentNo intervention 0 interventions
Group C: Asthma - sleep apnoea, treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in airflow variability measured by home electronic peak flow monitoring

Airflow variability will be assessed using peak expiratory flow rate (PEFR) measured with electronic home peak flow meters. Variability will be calculated using the daily amplitude percent mean (DAPM) method. Participants will be asked to record PEFR twice daily (early morning and late afternoon) over the defined period to provide adequate data points. For each day, variability will be calculated using the DAPM formula, and the average daily variability across the collection period will then be derived.

Time frame
3-4 months

Secondary outcomes

1

Change in asthma control

As measured by; -Asthma Control test (ACT) scoring

Time frame
3-4 months
2

Change in asthma control

As measured by; -Asthma quality of life questionnaire (AQLQ) score

Time frame
3-4 months
3

Change in asthma control

Exacerbation frequency

Time frame
3-4 months
4

Change in asthma control

Change in airway inflammation markers (FeNO)

Time frame
3-4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. James's Hospital, Ireland

Lead sponsor

Tallaght University Hospital

Collaborator

Source ClinicalTrials.gov
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