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

NCT ID: NCT02732912

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-25
• Study Completion Date: 2017-02-13

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

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Zopiclone

Intervention Type: DRUG

This night sedation will be given to any patient requesting it, in either group

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.

Group Type: EXPERIMENTAL

Ear plugs

Intervention Type: DEVICE

The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.

Eye Mask

Intervention Type: DEVICE

The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.

Zopiclone

Intervention Type: DRUG

This night sedation will be given to any patient requesting it, in either group

Interventions

Ear plugs

The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.

Intervention Type: 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.

Intervention Type: DEVICE

Zopiclone

This night sedation will be given to any patient requesting it, in either group

Intervention Type: DRUG

Other Intervention Names

Zimovane

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Adam Monk

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derick T Wade, MD

Role: PRINCIPAL_INVESTIGATOR

Oxford Centre for Enablement, Oxford University Hospitals NHS FT, Windmill Road, Oxford OX3 7HE, United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SleepSure

Identifier Type: -

Identifier Source: org_study_id