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

NCT04185818 | Unknown

• 1 other identifier: HRB.ThePeople'sTrial
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

sleep, book, read, bed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Reading group

EXPERIMENTAL

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

Other: Reading a book

Control Group

NO INTERVENTION

Participants will: 1\. Not read a book

Interventions

Reading a book OTHER

Participants requested to specify usual genre of book they read. 1. Fiction 2. Non-Fiction 3. Other 4. Don't usually read a book in bed

Reading group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age on enrollment;
• English speaking;
• ability to read;

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

National University of Ireland Galway

Galway, Co. Galway, H91 TK33, Ireland

Location

Related Publications (2)

• 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.

  PMID: 35264220 DERIVED

• 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.

  PMID: 34996514 DERIVED

MeSH Terms

Conditions

Bornholm Eye Disease

Study Officials

• Declan Devane, Professor

  National University of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, HRB-Trials Methodology Research Network

Model Details: The People's Trial is an online pragmatic, randomised controlled trial.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 4, 2019
• Study Start: December 4, 2019
• Primary Completion: February 29, 2020
• Study Completion: April 1, 2020
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)