Chronotherapy (timed ingestion of medicine) for high blood pressure in patients with obstructive sleep apnoea (OSA)

Phase 4

Completed

• Conditions: Hypertension; Obstructive Sleep Apnoea; Cardiovascular - Hypertension; Respiratory - Sleep apnoea

• Registration Number: ACTRN12611000216910
• Lead Sponsor: Dr C Phillips - Principle Investigator

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-28
• Study Completion: 2015-07-28
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified