SleepNCT04185818
Citizen Science: The People's Trial: A Randomised Controlled Trial
A study testing Reading a book in people with Sleep, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Reading a book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIreland
- Study dates
- 4 Dec 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age on enrollment;
- English speaking;
- ability to read;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Ireland1 site
National University of Ireland Galway
Galway, Co. Galway, H91 TK33
About this study
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.
Read the 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
- Conditions
- Sleep
- Being tested
- Reading a book
- Keywords
- sleep, book, read, bed
- Medical subject headings
- Bornholm Eye Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading a bookOther
Participants requested to specify usual genre of book they read.
- Fiction
- Non-Fiction
- Other
- Don't usually read a book in bed
| Study group | Role | What they receive |
|---|---|---|
| Reading group | Experimental | Participants will:
1. Read a book for 15 to 30 mins
2. Read immediately before trying to go to sleep. Receives: Other: Reading a book |
| Control Group | No intervention | Participants will: 1. Not read a book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From time of randomisation- refers to sleep in the last 7 days only
Secondary outcomes (2)
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
Measured: 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).
Measured: From time of randomisation- refers to sleep in the last 7 days only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start4 Dec 2019
- Primary completion29 Feb 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The People's Trial is an online pragmatic, randomised controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Prof. Declan Devane, National University of Ireland, Galway, Ireland
- Investigators
- Declan Devane, Professor, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185818
- Sponsor's protocol ID
- HRB.ThePeople'sTrial
- Status last verified
- Jan 2020
- First submitted
- 28 Nov 2019
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35264220Finucane 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.
PubMed 34996514
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citizen Science: The People's Trial: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04185818
- Acronym / sponsor ID
- HRB.ThePeople'sTrial
- Conditions
- Sleep
- Keywords
- sleep, book, read, bed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The People's Trial is an online pragmatic, randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Reading group | Experimental | Other: Reading a bookParticipants will: 1. Read a book for 15 to 30 mins 2. Read immediately before trying to go to sleep. |
| Control Group | No intervention | –Participants will: 1. Not read a book |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age on enrollment;
- English speaking;
- ability to read;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reading a bookParticipants 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 | Other | Reading group |
Primary outcome
Overall sleep quality
Time frame: From time of randomisation- refers to sleep in the last 7 days only
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)
2 secondary outcomes
Sleep Disturbance
Time frame: From time of randomisation- refers to sleep in the last 7 days only
Daytime sleepiness
Time frame: From time of randomisation- refers to sleep in the last 7 days only
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 35264220Finucane 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.
- Derived from this study: PubMed 34996514Finucane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Declan Devane, Professor principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading a book in people with Sleep, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall sleep quality (time frame: From time of randomisation- refers to sleep in the last 7 days only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185818, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020; AzTrials last refreshed its copy on 5 Nov 2026.