Sunrise in Obstructive Sleep Apnoea Study (SOSA) A Comparison of the Sunrise Mandibular Movement Monitoring Device With Overnight Oximetry and WatchPAT in the Diagnosis and Management of Obstructive Sleep Apnoea.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The proportion of patients for which a definitive management decision can be made when tested with Sunrise will be determined and compared to that of oximetry and WatchPAT 300.
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the Sunrise device (that measure small jaw movements) can improve the diagnosis and management of Obstructive Sleep Apnoea (OSA) in adults (≥ 18 years) referred to a Sleep Clinic.
The main question it aims to answer are:
- Does Sunrise lead to a higher proportion of definitive management decisions (initiate OSA treatment, discharge from the sleep clinic service, additional diagnostic testing required or a clinic appointment) compared to current screening practices, which includes either overnight oximetry or use of a wearable device called WatchPAT 300?
Researchers will compare Sunrise results with oximetry and WatchPAT 300 outcomes to see if Sunrise improves diagnostic efficiency, reduces time to a diagnosis or clinical decision and enhances patient experience.
Participants will:
- Follow the standard clinical pathway (oximetry or WatchPAT 300)
- Use the Sunrise device simultaneously for one night with their usual test
- Complete a patient feedback questionnaire on ease of use and experience
- Return all equipment two days later, Sunrise results will not affect their clinical care and will be used for the study only
详细描述
The study was designed to answer whether Sunrise can be used as an alternative sleep diagnostic test in an existing clinical pathway. Previous research has validated the device against Gold Standard testing - full polysomnography and polygraphy. Previous research has deemed the Sunrise device demonstrated a 92% accuracy when comparing full polysomnography to Sunrise and another study demonstrated 88-100% accuracy depending on OSA severity when tested in a patients home instead of an in patient sleep laboratory. Future research suggested evaluating the Sunrise device in a variety of care pathways and suggested patient experience to be considered.
The NICE guidance published 19/12/24, reviewing novel home testing devices for OSA highlights gaps in the research, including the need to review the accuracy in home testing devices at diagnosing and assessing OSA severity in patients with brown or black skin. University Hospitals Bristol and Weston NHS Foundation Trust sleep department receives referrals from all ethnic groups and we plan to include a range of ethnicity in our study.
This study aims to address research gaps by comparing the performance of Sunrise with oximetry and WatchPAT in the assessment of patients with suspected OSA to consider whether it could be incorporated into a standard diagnostic pathway. This will be done in an existing clinical service along side the current clinical care pathway, a range of ethnicity being referred into the service will be screened for recruitment. A patient feedback questionnaire will be issued to the patient on the usability of Sunrise device. There are currently no published studies reviewing Sunrise in a clinical pathway or comparing against diagnostic tests other than polygraphy or full polysomnography.
If the hypothesis is proven, Sunrise has the advantage of requiring no reporting time and can be conveniently posted to patients, and is therefore potentially a viable alternative test for the diagnosis of OSA, speeding up the patient pathway and reducing waiting times. Nationally, waiting sleeps for sleep diagnostic testing is increasing and services are unable to keep up with demand, if the hypothesis is proven, the Sunrise device could be implemented nationally and other sleep services may benefit from this research. This study could also address patient feedback and complaints by avoiding attending the department and subsequently improve patient experience.
This research is being conducted as part of the Principal Investigators HSST doctorate. Methodology training has been provided through planned lecture material delivered by MMU, competing the Good Clinical Practice certificate and competing additional learning through the Research Integrity Training certificate through MMU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
- The Principal Investigator (PI) and Clinical fellow will be blinded to the CRF after visit 1 to help ensure unbias analysis and triaging of Sunrise results. The database manager will complete the CRF after this point and update the study spreadsheet with the results.
- Sunrise results will be triaged by the PI and the clinical fellow. Both will be blinded to the oximetry and WatchPAT 300 triage outcome.
- The unblinded investigators within UHBW will be the co-investigator and the trial database manager.
- The PI and clinical fellow who will be triaging the Sunrise result will be blinded to the results of the WatchPAT 300 or oximetry result, and the clinical management decision made based on the WatchPAT 300 or oximetry result.
Once data collection and triaging has finished, the oximetry and WatchPAT 300 result and the clinical management decision made on those results will be made available to the PI to analyse the study outcomes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adults (aged ≥18 years old) referred with suspected Obstructive Sleep Apnoea
- •Patient has capacity to provide informed consent
- •Patient has access to a smartphone with Bluetooth and WiFi or internet data to download the Sunrise app and to transmit the Sunrise results to the Sunrise portal. UHBW Trust Wi-Fi available to the patient at equipment collection and return if needed.
- •Willing and able to comply with the study-specific procedures
- •Ability to read and comprehend English or understand simple device user instructions with guided pictures in English.
排除标准
- •• Suspected diagnosis of a sleep disorder other than OSA (including central sleep apnoea, parasomnias, narcolepsy, idiopathic hypersomnia)
- •Suspected chronic hypercapnic respiratory failure (history of acute hypercapnic respiratory failure, raised CO2 or serum bicarbonate)
- •Patients with unstable cardiovascular disease or non-arteritic anterior ischaemic optic neuropathy
- •Patients with beards who are unwilling to shave the area below their lip (the soul patch)
- •Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint
- •Unable to consent or lacks capacity to provide informed consent
- •In-patient referrals
- •Unwilling or unable to comply with the study-specific procedures.
- •Patients who have requested in their medical notes not to be involved in research or not to receive digital communication
结局指标
主要结局
The proportion of patients for which a definitive management decision can be made when tested with Sunrise will be determined and compared to that of oximetry and WatchPAT 300.
时间窗: • Patients recruited into the study will be issued the Sunrise device to use simultaneously for one night with oximetry or WatchPAT 300. • Patient exits the study when both devices are returned. • Sunrise results will be triaged by the PI and fellow
* The Principal Investigator (PI) will be blinded to the CRF after visit 1 to help ensure unbias analysis and triaging of Sunrise results. The database manager will complete the CRF after this point and update the study spreadsheet with the results. * Patients will return the Sunrise device the same time as their oximetry or WatchPAT 300. * Patient exits the study at this point. No further study requirements from the patient. * Sunrise results will be triaged by the PI and the clinical fellow. Both will be blinded to the oximetry and WatchPAT 300 triage outcome. * Hypothetical management plan following Sunrise Triage i) CPAP set up; ii) further diagnostic testing or iii) discharge from sleep service) iv) clinic appointment for further discussion. * The patient referral letter and new patient questionnaire will be consulted after Sunrise data hypothetical managements are determined, to compare the patient's clinical pathway following current practice and a CRF completed.
次要结局
未报告次要终点
研究者
Virginia Hawkins
Chief Investigator - Senior Lecturer
Manchester Metropolitan University