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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04185818
• Other study ID #: HRB.ThePeople'sTrial
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: January 2020
• Source: National University of Ireland, Galway, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: April 1, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
Ireland	National University of Ireland Galway	Galway	Co. Galway

Sponsors (2)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	Health Research Board, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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