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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep
• Intervention / Treatment: Other: Reading a book

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

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co. Galway
    • Galway, Co. Galway, Ireland, H91 TK33
      • National University of Ireland Galway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: Health Research Board, Ireland
• Investigators: Principal Investigator: Declan Devane, Professor, National University of Ireland, Galway

Publications and helpful links

General Publications

• Finucane E, O'Brien A, Treweek S, Newell J, Das K, Chapman S, Wicks P, Galvin S, Healy P, Biesty L, Gillies K, Noel-Storr A, Gardner H, O'Reilly MF, Devane D. The People's Trial: supporting the public's understanding of randomised trials. Trials. 2022 Mar 9;23(1):205. doi: 10.1186/s13063-021-05984-1.
• Finucane E, O'Brien A, Treweek S, Newell J, Das K, Chapman S, Wicks P, Galvin S, Healy P, Biesty L, Gillies K, Noel-Storr A, Gardner H, O'Reilly MF, Devane D. Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed? The People's Trial-an online, pragmatic, randomised trial. Trials. 2021 Dec 4;22(1):873. doi: 10.1186/s13063-021-05831-3.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Anticipated): February 29, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: sleep, book, read, bed
• Other Study ID Numbers: HRB.ThePeople'sTrial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No