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

National University of Ireland, Galway, Ireland

Status: Unknown

Conditions: Sleep

Treatments: Other: Reading a book

Study type: Interventional

Funder types: Other

Identifiers

NCT04185818

HRB.ThePeople'sTrial

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Reading group

Experimental group

Description:

Participants will: 1. Read a book for 15 to 30 mins 2. Read immediately before trying to go to sleep.

Treatment:

Other: Reading a book

Control Group

No Intervention group

Description:

Participants will: 1. Not read a book