The Effect of Continuous Positive Airway Therapy on the Blood Pressure in Sleepy vs Non-sleepy Patients With Obstructive Sleep Apnea
Key facts
- Who runs it
- King's College London
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 10,000 people, planned
- Started
- 1 Jan 2026
- Expected to end
- Jun 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Primary airway therapy (e.g., CPAP)
- Control arm
- Record updated
- 27 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Data for the individual patient data (IPD) meta-analysis, as published in the ANDANTE database (Pengo et al, European Respiratory Journal 2025)
- Patient with OSA (apnoea hypopnea index, AHI > 5/hour)
- age > 18 years
- previous inclusion in published randomised controlled trial using primary airway therapy (intervention) or in the control arm
Who cannot take part
- Not included in a randomised controlled trial to treat OSA
- not included in the ANDANTE database
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Obstructive sleep apnoea (OSA) is one of the most common noncommunicable types of disease, it affects about 1 billion people across the world. Left untreated, it causes apnoeas and hypopnoeas to fragment sleep, with frequent arousal from sleep and intermittent hypoxia associated with increased work of breathing. Frequently, it leads to excessive daytime sleepiness, as measured subjectively by the Epworth Sleepiness Scale, or, objectively, by the multiple sleep latency test (MSLT) or the maintenance of wakefulness test (MWT). OSA can lead to sustained high sympathetic tone at night, which in the long-term may impact on the cardiovascular risk.
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The investigators hypothesised that any primary airway therapeutic effect on the cardiovascular system, as measured by the blood pressure, in patients with OSA will differ dependent on whether subjects are excessively sleepy, or remain so when treated.
Hypothesis
1. Office blood pressure (SBP, DBP) responses to CPAP in patients with OSA who are excessively sleepy (ESS>10) at baseline vs non-sleepy patients at baseline. 2. 24-hour BP data (SBP, DBP, dipping, nocturnal and daytime) in sleepy patients in response to CPAP vs non-sleepy patients. 3. Adherence to treatment in sleepy patients may be different to non-sleepy patients and the observed effect effects will be adjusted in a secondary analysis according to available adherence data and follow up time.
The 2 groups in the trial
- Sleepy patients with OSA
Patients with obstructive sleep apnea who are excessively sleepy, as measured by the Epworth Sleepiness Scale (ESS) \> 10 points
Treatment: Primary airway therapy (e.g., CPAP) and Control arm
- Non-sleepy patients with OSA
Patients with obstructive sleep apnea who are not excessively sleepy, as measured by the Epworth Sleepiness Scale (ESS) \<= 10 points
Treatment: Primary airway therapy (e.g., CPAP) and Control arm
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Primary Airway Therapy on Blood Pressure in Excessively Sleepy Patients With Obstructive Sleep Apnoea: a Retrospective Analysis of the ANDANTE Data
- Record updated
- 27 March 2026