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

NCT02732912 | Completed Phase 3 Results

• 1 other identifier: SleepSure
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep

Keywords

falls; sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Length of Stay

  From date of admission to date of discharge, up to 90 days

• Use of Zopiclone (Night Sedation)

  From date of admission to date of discharge, up to 90 days

• Number of Falls

  From date of admission to date of discharge, up to 90 days

Other Outcomes (1)

• Use of Intervention

  At end of first night in hospital (first morning in hospital)

Study Arms (2)

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.

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.

Device: Ear plugs; Device: Eye Mask; Drug: Zopiclone

Interventions

Ear plugs 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 and ear plugs

Eye Mask 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 and ear plugs

Zopiclone DRUG

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

Also known as: Zimovane

Control; Eye mask and ear plugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

MeSH Terms

Interventions

Ear Protective Devices; zopiclone

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Less than 400 (target) recruited due to finances insufficient and delays in starting

Results Point of Contact

• Title: Dr Derick Wade
• Organization: Oxford Brookes University

derick.wade@ntlworld.com

+447818452133

Study Officials

• Derick T Wade, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomised, investigator-blinded, parallel group design

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 11, 2016
• Study Start: November 25, 2016
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share