Academic Journal

FOUND Trial: randomised controlled trial study protocol for case finding of obstructive sleep apnoea in primary care using a novel device

التفاصيل البيبلوغرافية
العنوان: FOUND Trial: randomised controlled trial study protocol for case finding of obstructive sleep apnoea in primary care using a novel device
المؤلفون: Jeremy Dale, Emma Scott, A Smith, Francesco P Cappuccio, Anne Smith, Ly-Mee Yu, R Harrison, A Ali, Michelle A Miller, J Harris, C Carr, A Hare, Peter Auguste, M Miller, J Dale, N Siriwardena, E Scott, C Rogers, L-M Yu, P S Sever, S Prakash, T J Peters, A Grove, T M MacDonald, K Hope, Asad Ali, C Taggart, T Quinnell, F P Cappuccio, J Guest, Jenna Grabey, Milensu Shanyinde, Patricia Apenteng, Kath Hope, I Mcleod, P Auguste, P Apenteng, O Dessi, O Llion, J Rahman, E Buckingham, J Chalk, J Grabey, M Shanyinde, L Costello, S Elwell
المصدر: BMJ Open, Vol 14, Iss 7 (2024)
بيانات النشر: BMJ Publishing Group
سنة النشر: 2024
المجموعة: Directory of Open Access Journals: DOAJ Articles
مصطلحات موضوعية: Medicine
الوصف: Introduction Obstructive sleep apnoea (OSA) is a common, but underdiagnosed, sleep disorder. If untreated, it leads to poor health outcomes, including Alzheimer’s disease, cancer, cardiovascular disease and all-cause mortality. Our aim is to determine the feasibility and cost-effectiveness of moving the testing for OSA into general practice and how general practitioner (GP)-based screening affects overall detection rates.Methods and analysis Randomised controlled trial of case finding of OSA in general practice using a novel Medicines and Healthcare products Regulatory Agency-registered device (AcuPebble SA100) compared with usual care with internal feasibility phase. A diverse sample of general practices (approximately 40) from across the West Midlands Clinical Research Network will identify participants from their records. Eligible participants will be aged 50–70 years with body mass index >30 kg/m2 and diabetes (type 1 or 2) and/or hypertension (office blood pressure >145/90 mm Hg or on treatment). They will exclude individuals with known OSA or chronic obstructive pulmonary disease, or those they deem unable to take part. After eligibility screening, consent and baseline assessment, participants will be randomised to either the intervention or control group. Participants in the intervention arm will receive by post the AcuPebble sleep test kit. Those in the control arm will continue with usual care. Follow-up questionnaires will be completed at 6 months. The study is powered (90%) to detect a 5% difference and will require 606 patients in each arm (713 will be recruited to each arm to allow for attrition). Due to the nature of the intervention, participants and GPs will not be blinded to the allocation.Outcomes Primary: Detection rate of moderate-to-severe OSA in the intervention group versus control group. Secondary: Time to diagnosis and time to treatment for intervention versus control group for mild, moderate and severe OSA; cost-effectiveness analysis comparing the different testing ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
تدمد: 2044-6055
Relation: https://bmjopen.bmj.com/content/14/7/e090000.full; https://doaj.org/toc/2044-6055; https://doaj.org/article/f8216baa35374a3e8415630d0fa6f0a3
DOI: 10.1136/bmjopen-2024-090000
الاتاحة: https://doi.org/10.1136/bmjopen-2024-090000
https://doaj.org/article/f8216baa35374a3e8415630d0fa6f0a3
رقم الانضمام: edsbas.7C4EFB26
قاعدة البيانات: BASE
الوصف
تدمد:20446055
DOI:10.1136/bmjopen-2024-090000