Pilot for a National Virtual Trial Testing Remote Sleep Apnea Evaluation in Patients with Atrial Fibrillation - (Mini VIR-SAAF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Drop-outs
研究概览
简要总结
This is an investigator-initiated virtual (or decentralized) trial that includes a postal parcel (mail-in) containing sensors for SA diagnosis (NightOwl™) and physical activity (SENS Motion), in addition to smart-phone based heart rhythm (FibriCheck) monitoring in participants with paroxysmal or persistent AF. A case-coordinator (the investigators) will manage all participant contacts virtually during the study from inclusion to follow-up.
详细描述
Objectives The main aim of the pilot trial is in a completely decentralized/virtual setting to evaluate whether SA home-evaluation, physical tracking by a home-monitoring device and heart rhythm monitoring by a smart-phone application in patients with AF are feasible.
Inclusion:
Confirmation of study eligibility will be performed entering key variables (including telephone number) into a secure web based program (RedCap) at the Cardiovascular Research Center at Herlev-Gentofte Hospital.
After inclusion, participants will receive a mail-in package containing the NightOwl™ device and the SENS Motion device. Online questionnaires for survey 1 will be pushed to participants via RedCap, which includes basic participant information (including mail, address, height, weight, (BMI), self-measured neck circumference and employment status) and the questionnaires Atrial Fibrillation Effect on QualiTy-of-life (AFEQT), AF severity scale (AFSS), Pittsburgh Sleep Quality Index (PSQI) and The eHealth Literacy Questionnaire (eHLQ).
Furthermore a clinical evaluation form will be filled out online in RedCap by the case coordinator based on electronic charts or from the video meeting which includes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age>18 years
- •Established paroxysmal or persistent AF diagnosis
- •Owning a compatible smartphone (or accepting a smart phone provided by the investigators)
- •Understanding of potential SA treatment possibilities including CPAP treatment
排除标准
- •Previous investigation for sleep-disturbed breathing
- •Advanced heart failure (left ventricular dysfunction and NYHA III/IV)
- •Occupational driver licenses
- •Pregnancy
- •Doxazosin or Terazosin (alpha-adrenergic antagonists)
- •Peripheral arterial disease with daily intermittent claudication
结局指标
主要结局
Drop-outs
时间窗: 3 months
The primary outcome of this pilot trial is the percentage of drop-outs (defined as not completing the 12 week study period) in participants given informed consent and having received the mail-in package.
次要结局
未报告次要终点
研究者
Morten Lamberts
Associate Professor
Herlev and Gentofte Hospital