SleepPhase 3NCT02732912
SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
A Phase 3 study testing Ear plugs, Eye Mask and Zopiclone in people with Sleep, run by Oxford University Hospitals NHS Trust.
Trial summary
The aim of this study is to determine whether routinely providing patients admitted to hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients having a better quality of sleep and/or longer, more satisfying sleep. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- Ear plugs, Eye Mask and Zopiclone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2016to 13 Feb 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age.
- Be expected to stay in Oxford University Hospitals National Health Service (NHS) Foundation Trust for at least one night.
- Be able to understand and use earplugs and eye mask.
- Have basic understanding of English reading and writing.
- Be considered likely to have the Mental Capacity to give consent for use of personal data in the study at the point of filling in the SleepSure Questionnaire (time of discharge). Data will not be collected from individuals who are unable to give consent with the filling in of the SleepSure questionnaire.
- Be expected to be able to fill in the SleepSure Questionnaire at the point of discharge with or without assistance.
Who cannot join
- They have or are expected to have an obvious medical contra-indication to the use of earplugs and eye mask at the point of enrollment e.g. eye infection, as per clinical judgement of recruiter.
- They are unlikely to benefit from the intervention in the judgement of the recruiter (i.e. individuals who are deaf and blind).
About this study
Official title: SleepSure: A Randomised Controlled Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
The aim of this study is to determine whether routinely providing patients admitted to hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients having a better quality of sleep and/or longer, more satisfying sleep.
Read the detailed description
This is a prospective, investigator blinded, randomised controlled study involving all patients admitted to any of ten acute wards in a large, busy hospital serving both the local population of about 700,000 people and a wider area for specialist services.
Patients will be identified at the time of admission and recruited as soon as possible by nursing and medical staff involved in the admission process. The primary exclusion criterion is some obvious reason that using the equipment is not possible (e.g. allergy to materials used).
After gaining consent, from the patient, or assent from a relative if the person is unable to consent at the time, the patient will be registered and allocated a number. Each ward will have prefilled envelopes with a randomly determined group allocation within it, and after registration this will be opened to determine the patient's group. Each patient will be given a short information leaflet and consent form.
Patients allocated to the intervention will be given the ear plugs and eye mask (in a plastic wallet, with instructions) and will be informed about their use.
On the next morning (i.e. after the first night in hospital) the patient will be approached and asked if he or she agrees to provide outcome information. Specifically patients who were unable to give consent initially (or do not recall doing so) will have the project explained again.
Provided the patient agrees, he or she will be given a SleepSure questionnaire to answer (with help if needed); this asks about quality and quantity of sleep, and use of aids to sleep.
After discharge a researcher will also extract from the patient's clinical record (which is on computer, not paper) information such as length of stay and use of night sedation (zopiclone). Basic demographic data will be extracted, and the hospital's incident reporting system (also on computer) will be checked to identify any falls.
All data will be recorded on a computerised data-base, anonymously, and the primary analysis will be a comparison of the two groups in terms of sleep quality, with secondary analyses investigating differences in rate of recorded falls, total amount of sleep medication used during hospital stay, and length of stay
- Conditions
- Sleep
- Being tested
- Ear plugs, Eye Mask, Zopiclone
- Keywords
- falls, sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear plugsDevice
The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.
Eye MaskDevice
The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.
ZopicloneDrug
Also called Zimovane
This night sedation will be given to any patient requesting it, in either group
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in this arm will continue current standard management for sleep, which is largely reactive; if a patient requests night sedation or complains that they cannot sleep and that they want help, then zopiclone is prescribed, starting at 3.75 mg. Receives: Drug: Zopiclone |
| Eye mask and ear plugs | Experimental | General management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment. Receives: Device: Ear plugs; Device: Eye Mask; Drug: Zopiclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids.
SleepSure is a short questionnaire which asks the patient to rate their sleep using a 1-10 numerical rating scale for eight items covering the quality of their sleep (e.g. difficulty getting to sleep, interruptions). Two additional questions recorded the use of aids. It takes no more that 2-3 minutes to complete. The eight numerical rating scores are summed and divided by 8 to give a score from 1 (very good sleep) to 10 (very poor sleep).
Measured: At end of first night in hospital after recruitment (i.e. the next morning)
Secondary outcomes (3)
Length of Stay
Time in days from admission to discharge from hospital (not from ward). These data were derived from the hospital administration data-base.
Measured: From date of admission to date of discharge, up to 90 days
Use of Zopiclone (Night Sedation)
The number of patients taking zopiclone during their stay. Data was taken from the Electronic patient record and was not available for any patient not discharged at the end of the study (one in each group).
NOT the original intention of measuring "the total dose of zopiclone taken during the admission will be recorded; this is available from the electronic drug chart used in the hospital"
Measured: From date of admission to date of discharge, up to 90 days
Number of Falls
The number of falls, if any, will be extracted from the hospital incident recording system for the patient at the time of discharge. The data will be reported simply as the number of patients experiencing a fall; not the total number of falls experienced by the patients who had a fall. The data were taken from the electronic patient records and were not available for patients (n = 2) still in hospital at the time of discharge.
Measured: From date of admission to date of discharge, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start25 Nov 2016
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, investigator-blinded, parallel group design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Monk, Oxford University Hospitals NHS Trust
- Investigators
- Derick T Wade, MD, Principal investigator, Oxford Centre for Enablement, Oxford University Hospitals NHS FT, Windmill Road, Oxford OX3 7HE, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732912
- Sponsor's protocol ID
- SleepSure
- Status last verified
- Sep 2019
- First submitted
- 31 Mar 2016
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan is in place, but definitely data will be made available to anyone making a legitimate request
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SleepSure: A Randomised Controlled Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
- ClinicalTrials.gov ID
- NCT02732912
- Acronym / sponsor ID
- SleepSure
- Conditions
- Sleep
- Keywords
- falls, sleep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether routinely providing patients admitted to hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients having a better quality of sleep and/or longer, more satisfying sleep.
Detailed description
This is a prospective, investigator blinded, randomised controlled study involving all patients admitted to any of ten acute wards in a large, busy hospital serving both the local population of about 700,000 people and a wider area for specialist services.
Patients will be identified at the time of admission and recruited as soon as possible by nursing and medical staff involved in the admission process. The primary exclusion criterion is some obvious reason that using the equipment is not possible (e.g. allergy to materials used).
After gaining consent, from the patient, or assent from a relative if the person is unable to consent at the time, the patient will be registered and allocated a number. Each ward will have prefilled envelopes with a randomly determined group allocation within it, and after registration this will be opened to determine the patient's group. Each patient will be given a short information leaflet and consent form.
Patients allocated to the intervention will be given the ear plugs and eye mask (in a plastic wallet, with instructions) and will be informed about their use.
On the next morning (i.e. after the first night in hospital) the patient will be approached and asked if he or she agrees to provide outcome information. Specifically patients who were unable to give consent initially (or do not recall doing so) will have the project explained again.
Provided the patient agrees, he or she will be given a SleepSure questionnaire to answer (with help if needed); this asks about quality and quantity of sleep, and use of aids to sleep.
After discharge a researcher will also extract from the patient's clinical record (which is on computer, not paper) information such as length of stay and use of night sedation (zopiclone). Basic demographic data will be extracted, and the hospital's incident reporting system (also on computer) will be checked to identify any falls.
All data will be recorded on a computerised data-base, anonymously, and the primary analysis will be a comparison of the two groups in terms of sleep quality, with secondary analyses investigating differences in rate of recorded falls, total amount of sleep medication used during hospital stay, and length of stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomised, investigator-blinded, parallel group design
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: ZopiclonePatients in this arm will continue current standard management for sleep, which is largely reactive; if a patient requests night sedation or complains that they cannot sleep and that they want help, then zopiclone is prescribed, starting at 3.75 mg. |
| Eye mask and ear plugs | Experimental | Device: Ear plugs, Device: Eye Mask, Drug: ZopicloneGeneral management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age.
- Be expected to stay in Oxford University Hospitals National Health Service (NHS) Foundation Trust for at least one night.
- Be able to understand and use earplugs and eye mask.
- Have basic understanding of English reading and writing.
- Be considered likely to have the Mental Capacity to give consent for use of personal data in the study at the point of filling in the SleepSure Questionnaire (time of discharge). Data will not be collected from individuals who are unable to give consent with the filling in of the SleepSure questionnaire.
Key exclusion criteria (2 listed)
- They have or are expected to have an obvious medical contra-indication to the use of earplugs and eye mask at the point of enrollment e.g. eye infection, as per clinical judgement of recruiter.
- They are unlikely to benefit from the intervention in the judgement of the recruiter (i.e. individuals who are deaf and blind).
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 |
|---|---|---|
| Ear plugsThe patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. | Device | Eye mask and ear plugs |
| Eye MaskThe patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. | Device | Eye mask and ear plugs |
| ZopicloneAlso: ZimovaneThis night sedation will be given to any patient requesting it, in either group | Drug | Control, Eye mask and ear plugs |
Primary outcome
SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids.
Time frame: At end of first night in hospital after recruitment (i.e. the next morning)
SleepSure is a short questionnaire which asks the patient to rate their sleep using a 1-10 numerical rating scale for eight items covering the quality of their sleep (e.g. difficulty getting to sleep, interruptions). Two additional questions recorded the use of aids. It takes no more that 2-3 minutes to complete. The eight numerical rating scores are summed and divided by 8 to give a score from 1 (very good sleep) to 10 (very poor sleep).
3 secondary outcomes
Length of Stay
Time frame: From date of admission to date of discharge, up to 90 days
Use of Zopiclone (Night Sedation)
Time frame: From date of admission to date of discharge, up to 90 days
Number of Falls
Time frame: From date of admission to date of discharge, up to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan is in place, but definitely data will be made available to anyone making a legitimate request
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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.
Derick T Wade, MD principal investigator
Oxford Centre for Enablement, Oxford University Hospitals NHS FT, Windmill Road, Oxford OX3 7HE, United Kingdom
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ear plugs, Eye Mask and Zopiclone in people with Sleep, run by Oxford University Hospitals NHS Trust.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids. (time frame: At end of first night in hospital after recruitment (i.e. the next morning)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2019.