Clinical trial NCT02732912: SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
Official title: SleepSure: A Randomised Controlled Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep
Keywords: falls
sleep
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, investigator-blinded, parallel group design
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids.
timeFrame: At end of first night in hospital after recruitment (i.e. the next morning)
Secondary outcomes:
measure: Length of Stay
timeFrame: From date of admission to date of discharge, up to 90 days
measure: Use of Zopiclone (Night Sedation)
timeFrame: From date of admission to date of discharge, up to 90 days
measure: Number of Falls
timeFrame: From date of admission to date of discharge, up to 90 days
Other outcomes:
measure: Use of Intervention
timeFrame: At end of first night in hospital (first morning in hospital)
Locations:
Study officials:
affiliation: Oxford Centre for Enablement, Oxford University Hospitals NHS FT, Windmill Road, Oxford OX3 7HE, United Kingdom
name: Derick T Wade, MD
role: PRINCIPAL_INVESTIGATOR
References: