SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Drug: Zopiclone; Device: Ear plugs; Device: Eye Mask

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 Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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.	Drug: Zopiclone; This night sedation will be given to any patient requesting it, in either group; Other Names: Zimovane
Experimental: Eye mask and ear plugs; 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.	Drug: Zopiclone; This night sedation will be given to any patient requesting it, in either group; Other Names: Zimovane; Device: Ear plugs; The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.; Device: Eye Mask; The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At end of first night in hospital after recruitment (i.e. the next morning)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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"	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.	From date of admission to date of discharge, up to 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Intervention	The SleepSure questionnaire asks about use of the intervention on the night before.	At end of first night in hospital (first morning in hospital)

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Derick T Wade, MD, Oxford Centre for Enablement, Oxford University Hospitals NHS FT, Windmill Road, Oxford OX3 7HE, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2016
• Primary Completion (Actual): February 13, 2017
• Study Completion (Actual): February 13, 2017

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: sleep; falls
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Zopiclone
• Other Study ID Numbers: SleepSure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan is in place, but definitely data will be made available to anyone making a legitimate request