Status:
COMPLETED
OSA Recurrence in CPAP Withdrawal
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
OSA
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Continuous positive airway pressure (CPAP) therapy is the most effective Treatment for obstructive sleep apnoea (OSA ). However, adherence to CPAP is often limited. There are established and emerging ...
Detailed Description
Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder characterised by a repetitive collapse of the pharynx during sleep, which results in apnoea or hypopnoea associate...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥18-80 years. Objectively confirmed OSA with an apnoea-hypopnoea- index (AHI) or an oxygen desaturation index (ODI) of ≥20/h at the time of diagnosis (obstructive events).
- Effectively treated with CPAP for \> 6 months (AHI on CPAP \< 5/h, CPAP usage \> 4 hours/night \> 70% of the days).
- Exclusion criteria:
- Moderate to severe obstructive (FEV1/FVC \< lower limit of normal and FEV1 \< 70% predicted) or restrictive lung disease (FVC \< 60% predicted).
- Daytime pCO2 \> 6 kPa (45 mmHg).
- Central Sleep Apnoea/Cheyne Stokes Respiration. Unstable heart failure, untreated coronary artery disease, severe arterial hypertension (resting blood pressure \>180/110 mmHg).
- Co-existing non-respiratory sleep disorder (by history).
- Opioid or sedative use. Alcohol abuse.
- Current professional driver or comparable profession.
Exclusion
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03472612
Start Date
April 9 2018
End Date
October 1 2019
Last Update
March 15 2022
Active Locations (1)
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1
Guys and St Thomas NHS Foundation Trust
London, United Kingdom, SE1 7EH