Citizen Science: The People's Trial: A Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
Citizen Science: The People's Trial: A Randomised Controlled Trial

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Other: Reading a book


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The People's Trial is an online pragmatic, randomised controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reading group<br>Participants will: Read a book for 15 to 30 mins Read immediately before trying to go to sleep. | Other: Reading a book<br>* Participants requested to specify usual genre of book they read. Fiction Non-Fiction Other Don't usually read a book in bed<br>|
| No Intervention: Control Group<br>Participants will: 1. Not read a book | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall sleep quality | 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) | From time of randomisation- refers to sleep in the last 7 days only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Disturbance | This will be measured using the PROMIS Short Form Sleep Disturbance Scale which measures eight items on 5-point scale to rate the frequency of problems related to insufficient sleep in the past seven days | From time of randomisation- refers to sleep in the last 7 days only | 
| Daytime sleepiness | Perceptions of daytime sleepiness will be measured using a a single item with a 10-point scale. Respondents are instructed to indicate their sleepiness at that moment by choosing a number between 1 (not sleepy at all) and 10 (very sleepy). Others have found a single item to measure sleep quality produces reproducible and valid data (Cappelleri, et al 2009, Riegel et al 2013). | From time of randomisation- refers to sleep in the last 7 days only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, book, read, bed