None listed
Conditions
Brief summary
The project consists of a randomised controlled pilot trial to assess whether identification and treatment of obstructive sleep apnea (OSA) in patients with nocturnal hypertension using a previously-validated, general practice-based OSA care model, is: (1) feasible, acceptable and sustainable to patients and general practice staff; (2) clinically effective in improving patient outcomes, including nocturnal hypertension (primary outcome), OSA symptoms, mood and quality of life; and (3) associated with significant reductions in healthcare costs.
Interventions
Diagnosis, treatment and monitoring of obstructive sleep apnea in patients with nocturnal hypertension identified from within primary care, plus usual care for nocturnal hypertension (anti-hypertensive medications and lifestyle advice). The metropolitan GP practices will refer patients for usual OSA care to a specialist sleep centre for sleep study testing, sleep physician review and management. Patient care will involve standard care for patients with suspected OSA, and management decisions will be determined by the treating sleep physician. Usually, this will involve an initial review by a sleep physician, referral for a home or in-laboratory polysomnography, and, if found to have moderate-severe OSA, treatment with lifestyle advice, weight loss and CPAP therapy. Other non-CPAP therapies may also be suggested. The rural GP practices will provide OSA diagnostic testing within their practice using a limited-channel ApneaLink device, OSA management by the GP and CPAP administered by a practice nurse if OSA is confirmed, with sleep specialist advice provided when required. GPs and nurses will be trained on the use of ApneaLink equipment, OSA diagnosis and management. If patients are confirmed as having moderate-severe OSA, patients will be offered CPAP treatment that will be issued to them by the practice nurse. The fixed pressure setting on the CPAP device will be determined following a 1 week auto-CPAP titration study that will be arranged by the practice nurse. Rural GPs/nurses will be supported by specialist sleep services (sleep physicians and nurses), who will provide advice as needed via phone call, emails or teleconference calls, or formal consultation. All patients allocated to the intervention arm will receive in-home health monitoring devices (i.e. an under-mattress sensor mat, smart blood pressure and weight scales) connected via a mobile phone app and Wi-Fi to enable continuous feedback to the patient and their GP during the 4 month follow-up period. Study staff will be able to see if regular data is being collected from the health monitoring devices to assess compliance of recordings, as this data is uploaded to the cloud onto a secure website that is accessible by the research team.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Male and female patients aged at least 18 years from primary care clinic with nocturnal hypertension (nighttime BP greater than or equal to 120/70 mmHg and/or night-to-daytime ratio of mean BP of greater than 0.9) confirmed on ambulatory blood pressure monitoring. 2. Willing to use CPAP or non-CPAP treatment options if found to have OSA 3. Wi-Fi capability within the home environment and able/willing to use mobile phone app for smart monitoring devices.
Exclusion criteria
1. Patients currently/previously treated for OSA, 2. Pregnant women, 3. Unstable psychiatric disease or cognitive impairment considered likely to interfere with provision of informed consent, adherence to instructions, or completing the study questionnaires, 4. Severe morbid obesity (body mass index [BMI] greater than or equal to 50), 5. Presence of a severe, chronic disease, e.g., neoplasia, severe renal failure, neuromuscular disease, severe lung disease and/or on supplemental oxygen, unstable cardiovascular disease (recent hospitalisation in the past 3 months for myocardial infarction, unstable angina, heart failure or cerebrovascular accident; or New York Heart Association class III or IV symptoms), or other life-limiting disease, 6. Commercial or heavy vehicle drivers