None listed
Conditions
Brief summary
The aim of the study is to investigate the efficacy of chronotherapy (altering ingestion time of study medication Perindopril) to improve and provide a better overall control of hypertension in patients with Obstructive Sleep Apnoea.
Interventions
Following screening, patients on Angiotensin Converting Enzyme Inhibitors (ACE-i) or Angiotensin Receptor Blockers (ARBs) will undertake a washout period of 3 weeks. All patients will then undergo a run-in period with perindopril 10mg (morning dose) to ensure medication tolerability. The run in period will be 1 week for those previously taking ACE-i, 2 weeks for those previously on ARBs, and 4 weeks for all patients. Patients will then be randomised to one of two anti-hypertensive treatment orders for 6 weeks and then cross over to the alternative order. The two treatment orders are. Treatment Order 1: Perindopril 10 mg morning dose and placebo bedtime dose Treatment Order 2: Placebo morning dose and Perindopril 10mg bedtime dose There is no washout period between the two treatment orders. Following completion of both treatment orders, patients will continue with their last allocated anti-hypertensive treatment order (1 or 2) and also receive Continous Positive Airway Pressure (CPAP) treatment in an open label design for 8 weeks. CPAP will be delivered via a nasal mask and the pressure will be individually titrated during an in-laboratory pressure determination study prior to commencement of 8 weeks CPAP therapy. The pressure will be titrated to a level that fully prevents apnoeas and hypopneas and normalizes breathing during sleep. During the 8 weeks of CPAP treatment, patients will be encouraged to use the device every night for the entire sleep period.
Sponsors
Study design
Eligibility
Inclusion criteria
The maximum age is 65 years as stated below. This amendment was approved by the ethics committee on 01/06/2011.
Exclusion criteria
Pregnancy. Abnormal renal function or chronic kidney disease indicated by any of 1. raised creatinine (>110umol/L) 2. raised potassium (>5.0 mmol/L) 3. low eGFR (<60ml/min/1.73m2) Severe hypertension (SBP>=180 and/or DBP>=110) Drug resistant hypertension defined as taking more than 3 classes of BP medication Normal Office BP (< 140/90 mmHg) whilst taking anti-hypertensive medication that does not include an ACE or ARB. ACE Inhibitor intolerance (based on the opinion of participants and study physicians) indicated by the development of new cough or symptoms of hypotension (dizziness). Unwilling to undergo washout of ACE or ARB medication. Shift workers who rotate to night shift. Poorly controlled diabetes defined as Glycosolated Haemoglobin (HbA1c) >=8. Unstable Angina / Heart Failure (NYHA Class III and IV)/ Stroke. Recent (< 6 months) AMI or Revascularisation Procedure. Significant Arrhythmia or Atrial Fibrillation. Cognitive impairment / Psychiatric disorder / Physically unable to participate. Recent OSA treatment with Mandibular Advancement Splint or CPAP exposure (within 3 months of screening) or prior refusal of CPAP treatment. Severe OSA (minimum oxygen saturation < 65% or RDI > 80) or excessively sleepy patients at increased risk for driving-related accidents requiring immediate treatment. More than 20% of AHI with central apnoeas.