Clinical trial NCT04185818: Citizen Science: The People's Trial: A Randomised Controlled Trial
Official title: Citizen Science: The People's Trial: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Keywords: sleep, book, read, bed
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2019-12-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The People's Trial is an online pragmatic, randomised controlled trial.
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Overall sleep quality
timeFrame: From time of randomisation- refers to sleep in the last 7 days only
Secondary outcomes:
measure: Sleep Disturbance
timeFrame: From time of randomisation- refers to sleep in the last 7 days only
measure: Daytime sleepiness
timeFrame: From time of randomisation- refers to sleep in the last 7 days only
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: National University of Ireland Galway
state: Co. Galway
Study officials:
affiliation: National University of Ireland, Galway
name: Declan Devane, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.