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

• Sponsor: Oxford University Hospitals NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT02732912
• Collaborator: (none)
• Enrollment: 206
• Arms: 2
• Actual Duration (Months): 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Device: Ear plugs; Device: Eye Mask; Drug: Zopiclone	Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised, investigator-blinded, parallel group designRandomised, investigator-blinded, parallel group design
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: SleepSure: A Randomised Controlled Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
• Actual Study Start Date: Nov 25, 2016
• Actual Primary Completion Date: Feb 13, 2017
• Actual Study Completion Date: Feb 13, 2017

Arms and Interventions

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.	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.; Drug: Zopiclone; This night sedation will be given to any patient requesting it, in either group; Other Names: Zimovane

Outcome Measures

Primary Outcome Measures

1. SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids. [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).

Secondary Outcome Measures

1. Length of Stay [From date of admission to date of discharge, up to 90 days]

   Time in days from admission to discharge from hospital (not from ward). These data were derived from the hospital administration data-base.

2. Use of Zopiclone (Night Sedation) [From date of admission to date of discharge, up to 90 days]

   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"

3. Number of Falls [From date of admission to date of discharge, up to 90 days]

   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.

Other Outcome Measures

1. Use of Intervention [At end of first night in hospital (first morning in hospital)]

   The SleepSure questionnaire asks about use of the intervention on the night before.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• 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 Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 18, 2016

More Information

Publications

None provided.

• Responsible Party: Adam Monk, Principle Investigator, Oxford University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT02732912
• Other Study ID Numbers: SleepSure
• First Posted: Apr 11, 2016
• Last Update Posted: Oct 1, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Adam Monk, Principle Investigator, Oxford University Hospitals NHS Trust: falls; sleep
• Additional relevant MeSH terms: Zopiclone

Study Results

Participant Flow

Recruitment Details	Started 25 November 2016, Ended 13 February 2017 Recruited from medical and surgical wards in a large acute teaching and academic hospital in United Kingdom (UK)

Arm/Group Title	Control	Eye Mask and Ear Plugs
Arm/Group Description	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. Zopiclone: This night sedation will be given to any patient requesting it, in either group	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. Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Zopiclone: This night sedation will be given to any patient requesting it, in either group
Period Title: Overall Study
STARTED	97	109
COMPLETED	87	91
NOT COMPLETED	10	18

Baseline Characteristics

Arm/Group Title	Control	Eye Mask and Ear Plugs	Total
Arm/Group Description	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. Zopiclone: This night sedation will be given to any patient requesting it, in either group	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. Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Zopiclone: This night sedation will be given to any patient requesting it, in either group	Total of all reporting groups
Overall Participants	97	109	206
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.3	48.4	51.6
Sex: Female, Male (Count of Participants)
Female	51 52.6%	70 64.2%	121 58.7%
Male	46 47.4%	39 35.8%	85 41.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	97 100%	109 100%	206 100%
Ward type (Count of Participants)
Surgical wards	53 54.6%	54 49.5%	107 51.9%
Neuroscience	21 21.6%	21 19.3%	42 20.4%
Gynaecology	14 14.4%	26 23.9%	40 19.4%
Acute medical	5 5.2%	6 5.5%	11 5.3%
Geriatric	4 4.1%	2 1.8%	6 2.9%
Night after admission (Count of Participants)
First night	6 6.2%	4 3.7%	10 4.9%
Second night	41 42.3%	52 47.7%	93 45.1%
Third night	9 9.3%	16 14.7%	25 12.1%
Fourth night	12 12.4%	7 6.4%	19 9.2%
Fifth night	8 8.2%	6 5.5%	14 6.8%
sixth or later night	13 13.4%	12 11%	25 12.1%
No data returned	6 6.2%	9 8.3%	15 7.3%
Discharged before first night	2 2.1%	3 2.8%	5 2.4%

Outcome Measures

1. Primary Outcome

Title	SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids.
Description	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).
Time Frame	At end of first night in hospital after recruitment (i.e. the next morning)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Eye Mask and Ear Plugs
Arm/Group Description	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. Zopiclone: This night sedation will be given to any patient requesting it, in either group	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. Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Zopiclone: This night sedation will be given to any patient requesting it, in either group
Measure Participants	87	91
Mean (Standard Deviation) [units on a scale]	5.09 (2.05)	6.33 (2.13)

2. Secondary Outcome

Title	Length of Stay
Description	Time in days from admission to discharge from hospital (not from ward). These data were derived from the hospital administration data-base.
Time Frame	From date of admission to date of discharge, up to 90 days

Outcome Measure Data

Analysis Population Description

All patients were analysed. Two patients (one in each group) had not been discharged when data collection ended. In that instance, the number of days from recruitment to the end-of-study date was used.

Arm/Group Title	Control	Eye Mask and Ear Plugs
Arm/Group Description	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. Zopiclone: This night sedation will be given to any patient requesting it, in either group	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. Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Zopiclone: This night sedation will be given to any patient requesting it, in either group
Measure Participants	97	109
Mean (Standard Deviation) [days]	4.83 (6.21)	3.67 (3.71)

3. Secondary Outcome

Title	Use of Zopiclone (Night Sedation)
Description	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"
Time Frame	From date of admission to date of discharge, up to 90 days

Outcome Measure Data

Analysis Population Description

All patients were analysed. Two patients had not been discharged (one in each group) when data collection ended. In that instance, the number of doses of zopiclone could not be ascertained, and zero was used in the analysis.

Arm/Group Title	Control	Eye Mask and Ear Plugs
Arm/Group Description	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. Zopiclone: This night sedation will be given to any patient requesting it, in either group	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. Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Zopiclone: This night sedation will be given to any patient requesting it, in either group
Measure Participants	97	109
Count of Participants [Participants]	2 2.1%	3 2.8%

4. Secondary Outcome

Title	Number of Falls
Description	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.
Time Frame	From date of admission to date of discharge, up to 90 days

Outcome Measure Data

Analysis Population Description

All patients were analysed. Two patients, one in each group, had not been discharged when data collection ended and data on falls were not available. The value of zero falls was used.

Arm/Group Title	Control	Eye Mask and Ear Plugs
Arm/Group Description	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. Zopiclone: This night sedation will be given to any patient requesting it, in either group	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. Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Zopiclone: This night sedation will be given to any patient requesting it, in either group
Measure Participants	97	109
Count of Participants [Participants]	0 0%	0 0%

5. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Eye Mask and Ear Plugs
Arm/Group Description	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. Zopiclone: This night sedation will be given to any patient requesting it, in either group	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. Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Zopiclone: This night sedation will be given to any patient requesting it, in either group
Measure Participants	97	109
Ear plugs AND eye masks	0 0%	65 59.6%
Ear plugs ONLY	1 1%	1 0.9%
Eye mask ONLY	1 1%	13 11.9%
Neither ear plug or mask	87 89.7%	15 13.8%
Unknown	8 8.2%	15 13.8%

Adverse Events

Time Frame	The time frame was the period of inpatient care (i.e. from the time of recruitment to the time of discharge). Two patients remained in hospital at the end of the study data collection period, and for those two patients data in the hospital incident record up to that date was used.
Adverse Event Reporting Description	The hospital electronic incident system records all reported incidents, which are defined as unexpected events outside normal care pathways. This would (should) record all falls, and any other adverse events. If a patient died during the admission, the 'discharge' is recorded as a death. There was no prospective study-specific data collection on each patient. No incidents (adverse events) were recorded for any patient over the course of the study.
Arm/Group Title	Control		Eye Mask and Ear Plugs
Arm/Group Description	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. Zopiclone: This night sedation will be given to any patient requesting it, in either group		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. Ear plugs: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Eye Mask: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. Zopiclone: This night sedation will be given to any patient requesting it, in either group
All Cause Mortality
	Control		Eye Mask and Ear Plugs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/109 (0%)
Serious Adverse Events
	Control		Eye Mask and Ear Plugs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/109 (0%)
Other (Not Including Serious) Adverse Events
	Control		Eye Mask and Ear Plugs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/109 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.