Citizen Science: The People's Trial: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Overall sleep quality
研究概览
简要总结
The People's trial is an online pragmatic, randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.
详细描述
The People's Trial seeks to help enhance the public's understanding of randomised trials by facilitating the involvement of the public in the trial research process. The public have, through an online format, guided the development and design of The People's Trial randomised controlled trial. The People's trial is a parallel, online randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.
Members of the public will be recruited through online platforms. Informed consent will be obtained from all participants prior to trial registration. Consent forms will be provided online prior to registration for The People's Trial. Participants will be required to acknowledge that they have read the consent form and give consent to proceed with trail registration.
Participants will be randomly allocated into one of two groups:
Group 1: Reading a book in bed
Group 2: Not reading a book in bed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age on enrollment;
- •English speaking;
- •ability to read;
- •Exclusion criteria
- •Members of the public who are unwilling or unable to give informed consent.
- •Unable to go to bed and wake up at the same time as normal for the study duration.
- •Unable to sleep in their own bed, in their own home for the study duration
- •Unable to not eat food or drink caffeinated drinks within 1 hour of bed for the study duration
排除标准
- 未提供
结局指标
主要结局
Overall sleep quality
时间窗: From time of randomisation- refers to sleep in the last 7 days only
Sleep quality will be measured using the single item sleep quality scale (SQS) (Snyder et al 2018). The SQS is a self-administered questionnaire in which respondents rate overall quality of sleep over a 7-day recall period on a discretizing visual analogue scale from 0 to 10 (0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent)
次要结局
- Sleep Disturbance(From time of randomisation- refers to sleep in the last 7 days only)
- Daytime sleepiness(From time of randomisation- refers to sleep in the last 7 days only)
研究者
Prof. Declan Devane
Scientific Director, HRB-Trials Methodology Research Network
National University of Ireland, Galway, Ireland