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

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 pathways.

Ethics and dissemination
The trial started on 1 November 2022. Ethical approval was granted from the South Central Oxford A Research Ethics Committee on 9 June 2023 (23/SC/0188) (protocol amendment version 1.3; update with amendment and approval to renumber to V2.0 on 29 August 2023). Patient recruitment began on 7 January 2024; initial planned end date will be on 31 April 2025.
Results will be uploaded to the ISRCTN register within 12 months of the end of the trial date, presented at conferences, submitted to peer-reviewed journals and distributed via our patient and public involvement networks.
The University of Warwick will act as the trial sponsor. The trial will be conducted in accordance with the Sponsor and Primary Care Clinical Trials Unit standard operating procedures.

Trial registration number
ISRCTN 16982033.

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Protocol for a telephonic mixed methods study to understand needs and find solutions for bereaved dementia caregivers

Introduction
Most caregivers of people living with dementia will experience bereavement within 10 years, but study of and support for their needs rarely persists following the death of their care recipients. A single model that leverages theoretical insights as well as observation from lived experience might help identify who will have greater difficulty following dementia-related bereavement and suggest core mechanisms to target to relieve clinical and subclinical consequences. The millions of existing bereaved dementia caregivers likely have considerable insight into ways to improve experience. Rather than creating interventions from scratch, researchers might leverage those insights to more rapidly improve the lives of bereaved dementia caregivers.

Methods and analysis
This study uses a transformative mixed methods approach to explore the needs of caregivers for individuals with Alzheimer’s disease (AD) and AD-related dementias, incorporating both quantitative surveys (n=400) and qualitative semistructured interviews (n=45) across diverse subgroups. The study described in this protocol aims to quantitatively test a new model based on self-determination theory to help understand when and why bereaved dementia caregivers experience better and worse outcomes following bereavement. The study also aims to qualitatively explore the ways that bereaved dementia caregivers might meet their needs to inform future interventions.

Ethics and dissemination
The study adheres to institutional guidelines, ensuring participant consent and minimising risks through verbal consent procedures and the removal of personal identifiers from survey responses. The study team will share findings widely through academic publications, conferences and targeted outreach to advocacy groups and healthcare professionals, while also providing concise summaries of results to participants and making them accessible through the lab’s website.

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