Conditions: Sleep
Keywords: falls sleep
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 206
Healthy volunteers: no

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

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Ear plugs intervention 2: Eye Mask intervention 3: Zopiclone
Intervention descriptions: intervention 1: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. intervention 2: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep. intervention 3: This night sedation will be given to any patient requesting it, in either group

Protocol document:
Prot_SAP_000.pdf: 
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Study Title:  SleepSure: a randomised controlled trial to assess the effects of eye masks and earplugs on 
the quality of sleep for patients in hospital. 
Ethics Ref: 16/NW/0318 
Date and Version No: 18-11-16, version 10 
 
Chief Investigator: 
Dr  Adam Monk, Oxford University Hospitals NHS Foundation Trust 
Investigators:  
Andrew Finlay, FY2 at Royal Berkshire NHS Foundation Trust;  
Toshi Sherpa, FY2 at Royal Berkshire NHS Foundation Trust;  
Charlotte Lees, FY2 at Buckinghamshire Healthcare NHS Trust 
Professor Derick Wade 
Sponsor:  
Oxford University Hospitals NHS Foundation Trust 
Funder: 
Challenge 2023 
Chief Investigator Signature:   
There are no conflicts of interest to report. 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, host organisation, and members of the Research Ethics Committee, 
unless authorised to do so. 
 


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TABLE OF CONTENTS 
 
1. 
SYNOPSIS ............................................................................................................................................... 4 
2. 
ABBREVIATIONS ..................................................................................................................................... 4 
3. 
BACKGROUND AND RATIONALE ............................................................................................................ 5 
4. 
OBJECTIVES AND OUTCOME MEASURES ............................................................................................... 7 
5. 
STUDY DESIGN ....................................................................................................................................... 7 
6. 
STUDY PARTICIPANTS ............................................................................................................................ 8 
6.1. 
Study Participants .......................................................................................................................... 8 
6.3 
The Exclusion Criteria .................................................................................................................... 8 
7. 
STUDY PROCEDURES ............................................................................................................................. 8 
7.1. 
Recruitment ................................................................................................................................... 8 
7.2. 
Informed Consent .......................................................................................................................... 9 
7.3. 
Screening and Eligibility Assessment ............................................................................................. 9 
7.4. 
Randomisation, blinding and code-breaking ................................................................................. 9 
7.5. 
Baseline Assessments .................................................................................................................... 9 
7.6. 
Subsequent Visits ........................................................................................................................ 10 
7.7. 
Discontinuation/Withdrawal of Participants from Study ............................................................ 10 
7.8 
. Definition of End of Study ......................................................................................................... 10 
8. 
INTERVENTIONS ................................................................................................................................... 10 
9. 
SAFETY REPORTING ............................................................................................................................. 10 
9.1. 
Definition of Serious Adverse Events .......................................................................................... 10 
9.2. 
Reporting Procedures for Serious Adverse Events ...................................................................... 11 
10. 
STATISTICS AND ANALYSIS ............................................................................................................... 11 
10.1. 
Description of Statistical Methods .......................................................................................... 12 
10.2. 
The Number of Participants .................................................................................................... 12 
10.3. 
Analysis of Outcome Measures ............................................................................................... 12 
11. 
DATA MANAGEMENT ...................................................................................................................... 12 
11.1. 
Access to Data ......................................................................................................................... 12 
11.2. 
Data Recording and Record Keeping ....................................................................................... 12 
12. 
QUALITY ASSURANCE PROCEDURES ............................................................................................... 13 
13. 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................................................... 13 
13.1. 
Declaration of Helsinki............................................................................................................. 13 
13.2. 
Guidelines for Good Clinical Practice ...................................................................................... 13 


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13.3. 
Approvals ................................................................................................................................. 13 
13.4. 
Reporting ................................................................................................................................. 13 
13.5. 
Participant Confidentiality ....................................................................................................... 14 
13.6. 
Expenses and Benefits ............................................................................................................. 14 
13.7. 
Other Ethical Considerations ................................................................................................... 14 
14. 
FINANCE AND INSURANCE .............................................................................................................. 14 
14.1. 
Funding .................................................................................................................................... 14 
14.2. 
Insurance ................................................................................................................................. 14 
15. 
PUBLICATION POLICY ....................................................................................................................... 14 
16. 
REFERENCES .................................................................................................................................... 15 
 
 
 


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1. SYNOPSIS 
Study Title 
SleepSure: a randomised controlled trial to assess the effects of eye masks 
and earplugs on the quality of sleep for patients in hospital. 
 
Internal ref. no. / short 
title 
SleepSure: a study aimed at improving sleep for hospital inpatients 
Study Design 
Randomised Controlled Trial 
Study Participants 
Patients admitted to adult general medical and surgical wards at Oxford 
University Hospitals NHS Foundation Trust 
Planned Sample Size 
400 
Planned Study Period 
01 February 2016- 31 January 2017 
Pilot data collection 01 February 2016 to 14 February 2015 
Recruitment 01 March 2016 – 31 May 2016 (last follow-up 14 June 2016) 
 
Objectives 
Outcome Measures 
Primary 
 
Do earplugs and eye masks help 
hospital patients to sleep better? 
SleepSure Questionnaire, based on 
the validated Richards-Campbell 
Sleep Questionnaire 
Secondary 
 
 
 
 
 
 
Does the use of earplugs and eye 
masks lead to a reduced length of 
stay, reduced incidence of falls or 
reduced use of sleep aid medication? 
How many patients provided with 
earplugs and an eye mask choose to 
use them? 
Length of stay (days) 
Number of falls recorded during 
stay 
Doses of zopiclone (sleeping 
tablet) used to help sleep during 
stay 
Use of earplugs and eye masks 
(SleepSure sleep questionnaire) 
2. ABBREVIATIONS 
CI 
Chief Investigator 
CRF 
Case Report Form 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
ICF 
Informed Consent Form 
NHS 
National Health Service 
NRES 
National Research Ethics Service 
PI 
Principal Investigator 
PIL 
Participant/ Patient Information Leaflet 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedure 


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3. BACKGROUND AND RATIONALE 
 
Background 
Patients consistently complain of lack of sleep due to noises throughout the night from: patients, staff, 
machines and buzzers as well as complaining about bright lights being left on, monitors left active and 
LEDs flashing throughout the night(1,13). This has a severe negative impact on a patient’s hospital 
experience(8), and has been associated with increased risk of acute confusion(2),  increased medication 
usage(3) with their side-effects(4), delayed hospital discharge(5) (at a cost of £273 per day(6)) and worse 
health outcomes(7,8). In this project we aim to investigate whether the simple solution of earplugs and an 
eye mask can improve the inpatient experience through enhancing sleep.  
The question 
Our question is simple: Does the provision of earplugs and eye masks improve the sleep of hospital 
inpatients?    
Secondary questions are whether this provision leads to a reduced length of stay, reduced incidence of 
falls and reduced use of sleep aid medication.  We also wish to discover how many patients provided 
with earplugs and an eye mask choose to use them. 
The evidence 
Whilst use of earplugs and eye masks has a limited evidence base as a sleep adjunct in general hospital 
wards, there have been a number of small scale randomised trials in the intensive care unit setting 
where their use has been associated with: 
1) An objective improvement in night time sleep(9,10) 
2) A subjective enhancement of patient experience(11) 
3) A significant reduction and delayed incidence of acute confusion(12) 
4) A reduction in the use of morphine(10) 
 
The population 
The population studied will be individuals admitted to Oxford University Hospitals NHS Foundation Trust 
during the study period onto any ward admitting eligible patients for at least one night.  The precise 
inclusion and exclusion criteria will be defined more specifically later in the protocol. 
Risks to participants 
1) Allergies: Risk of patient or staff having an allergic reaction to the product.  
Likelihood: 1/5 Remote 
Severity: 4/5 Severe 
Total risk score: 4/25 low risk 
Mitigate risk by choosing earplugs and eye masks made from hypoallergenic materials, 
manufactured in quality plant approved with the CE mark. Earplugs and eye masks themselves or 
the literature provided with them will describe their composition/materials and they will only be 
provided to patients with the mental capacity to use them safely in an informed manner (similar 
to use on an aircraft). 
 


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2) Swallow/Choking risk: Risk of patients swallowing, breathing in and/or choking on earplugs. 
Likelihood: 1/5 Unlikely 
Severity: 4/5 Moderate risk 
Total risk score: 4/25 low risk 
Mitigate risk by restricting earplugs and eye masks to patient over 18 years old with capacity and 
awareness/ability to learning from information leaflets of how to use ear plugs/eye masks. 
 
3) Infection risk: Risk of spreading infections from one patient to another and of increasing risk of 
patients getting otitis externa (outer ear infections). 
Likelihood: 3/5 Possible 
Severity: 2/5 minor 
Total risk score: 6/25 Low risk 
Mitigate risk by advising patients with ear infections not to use earplugs. Have earplugs and eye 
masks as single patient use (for disposal on discharge) and replace earplugs and eye masks if 
soiled or contaminated. 
 
4) Pressure sores: Risk of earplugs and eye masks causing a pressure ulcer if left in the bed. 
Likelihood: 1/5 Remote 
Severity: 3/5 moderate 
Total risk score: 3/25 Low risk 
Mitigate risks by good nursing practice of checking the bed for anything lost on top of the 
mattress, making the bed daily and frequently turning patients with high risk of pressure ulcers, 
as well as pressure reducing mattresses and pressure removal from damaged sites. 
 
5) Increased confusion/risk of falls: increased confusion as patients forget to remove ear plugs and 
or eye masks and attempt to walk with ear plugs/eye masks still in place. NB/There is no evidence 
that this occurs, but it is conceivable that it could. 
Likelihood: 2/5 unlikely 
Severity: 3/5 moderate 
Total risk score: 6/25 Low risk 
Mitigate risk by never applying earplugs and eye masks to a patient without their express and 
informed request. Removing/not supplying ear plugs/eye masks to confused/confused patients 
who do not have mental capacity to use the aids.  
 
6) Missing alarms: risk of missing light and sound from fire alarms 
Likelihood: 2/5 Possible 
Severity: 2/5 Minor 
Total risk score: 4/25 Low risk 
Mitigate risk by ensuring nursing/healthcare staff wake and inform patients of fire alarm and 
mobilise them to the appointed safe place as is the routine fire protocol. Most patients are 
dependent upon healthcare staff to mobilise them regardless of their awareness of fire alarms. 
Most patients are also unable to distinguish between the differing alarms in hospital and are 
dependent upon staff for that information. 
 
 
 
 
 
 


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4. OBJECTIVES AND OUTCOME MEASURES 
 
Objectives 
Outcome Measures  
Timepoint(s) of evaluation of 
this outcome measure (if 
applicable) 
Primary Objective 
Do ear plugs and eyemasks 
improve inpatient experience of 
sleep? 
SleepSure sleep questionnaire 
Questionnaire given >1 day after 
recruitment 
Secondary Objectives 
A) How many patients provided 
with eye masks and earplugs 
choose to use them? 
SleepSure sleep questionnaire 
 
Questionnaire given >1 day after 
recruitment 
B) Does the use of earplugs and 
eye masks lead to reduced length 
of stay? 
Length of stay data from hospital 
administration system 
After discharge 
C) Does the use of earplugs and 
eye masks lead to reduced use of 
sleep aid medication? 
 
 
Drug chart data from electronic 
records. 
 
After discharge 
D) Does the use of earplugs and 
eye masks lead to a reduced 
incidence of falls? 
 
Falls data from centrally collated 
routinely collected information 
After discharge 
 
5. STUDY DESIGN 
 
Randomised controlled trial 
Pilot data collection 2 weeks from approval of study. 3 months data proper once pilot data has been 
reviewed and any required changes noted. Data collected from adult inpatients on 10 inpatient wards.  
Pilot data collection is to identify any problems with the data collection that may arise. If no changes to 
the protocol are made then this pilot data will be incorporated with the data proper. 
Targeted recruitment population:  400 patients total including up to 20 from pilot data.  Patients 
randomised to either intervention (earplugs and eye masks) or control (routine care). 
Intervention will be allocated via pre-performed simple randomisation concealed in opaque envelopes 
with intervention and non-intervention envelopes indistinguishable from one another which will be 
distributed in batches to each ward engaged in the study. 
SleepSure sleep questionnaire will be given to all patients >1 day after recruitment.  
 


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6. STUDY PARTICIPANTS 
6.1.  Study Participants 
Participants will be recruited from adult inpatients who meet the eligibility criteria and admitted to any 
participating wards in Oxford University Hospitals NHS Foundation Trust.  
 
6.2 
Inclusion criteria:  
Eligible candidates at the point of enrolment must: 
• 
Be 18 years of age 
• 
Be expected to stay in Oxford University Hospitals NHS Foundation Trust for at least one more 
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 (>1 day after recruitment).  NB/ 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 with or without assistance 
 
6.3 
The Exclusion Criteria 
Candidates will be excluded from the trial 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 enrolment eg. 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). 
 
7. STUDY PROCEDURES 
7.1. Recruitment 
A ward nurse, part of the direct care team on the ward, will approach potential participants on their 
arrival on the ward, usually as part of the admission assessment process. If they fulfil the inclusion 
criteria without exclusion characteristics the patient will be given a brief description of the study and a 


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Patient Information Sheet; with the permission of the patient any relatives present will also have the 
study explained and will be given a Patient Information Sheet. They will then be approached by the 
SleepSure research nurse who will consent and register the patient as a participant. 
7.2. Informed Consent 
Each patient considered eligible will be given a patient information sheet by a nurse on the ward, part of 
the direct care team. Following this they will be approached by the SleepSure research nurse who will 
give them a short verbal explanation that will cover: 
• 
The goal of the study (i.e. to study how to improve sleep) 
• 
The trial intervention (i.e. aircraft style earplugs and eye mask) 
• 
The fact that only a 50% chance of getting intervention (random allocation) 
• 
The collection of data (one questionnaire)  >1 day after recruitment 
• 
The collection and use of some routine hospital data (falls, use of sleeping tablets, length of stay) 
• 
The option to withdraw consent at any time 
• 
The specific action of having being presented with a SleepSure Questionnaire >1 day after 
recruitment, which if not filled in will be taken as a refusal of consent for the use of that data in 
the trial. 
A written consent form will be used. 
7.3. Screening and Eligibility Assessment 
As described above, there will be no initial gap between first contact and recruitment. 
7.4. Randomisation, blinding and code-breaking 
Every patient recruited will first be registered by the SleepSure research nurse onto an electronic 
password-protected Participant ID log in a secure location on the Trust network.  This will generate a trial 
number (e.g. WPH WdA 007 [hospital, ward, number]). 
Randomisation: 
Using a random number generator performing simple randomisation opaque numbered envelopes will 
be filled with a piece of paper stating control or intervention with an equal chance of each individual 
envelope containing a control or an intervention instruction. 50 sealed envelopes will be stacked into a 
box on each ward, each with a unique identifier number on the outside. When a potential participant is 
identified the SleepSure research nurse will go to the next envelope in the box and open it to determine 
if the patient is in the control or intervention arm. 
If the patient is allocated to the trial arm, the research nurse will give the patient a set of earplugs and an 
eyeshade, and explain their use, checking that the patient can use and remove them safely giving 
instruction as required.  The earplugs and eye mask will then be placed into a transparent plastic wallet, 
labelled with the patient’s name, the study and placed within easy reach of the patient. 
7.5. Baseline Assessments 


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No specific baseline assessment will be made, other than those needed to determine eligibility. 
7.6. Subsequent Visits 
At the final visit (>1 day after recruitment) the SleepSure research nurse will provide a SleepSure 
Questionnaire.  After discharge the participant’s anonymised ID number, age, gender, date of admission, 
date of discharge, length of stay, number of falls, doses used of zopiclone will be extracted from the 
notes and recorded by the SleepSure research nurse onto an Excel spreadsheet stored in a secure 
location on the Trust network with access only via a password-protected computer. The results of the 
SleepSure questionnaire will also be recorded onto this secure document at this time. (Please see section 
11 for more information.) 
7.7. Discontinuation/Withdrawal of Participants from Study 
Each participant has the right to withdraw from the study at any time.  In addition, the Investigator may 
discontinue a participant from the study at any time if the Investigator considers it necessary for any 
reason including: 
• 
Ineligibility (either arising during the study or retrospectively having been overlooked at screening) 
• 
Withdrawal of Consent 
• 
Allergy/ adverse event from intervention 
 
If a patient withdraws, or is withdrawn, the reason will be recorded.  If a patient dies during the 
admission, this will be recorded and the certified primary cause noted. 
7.8 . Definition of End of Study 
The end of study recruitment will be 3 months from the start date.  Follow-up data will be collected for a 
further two weeks.  Any patient remaining at that time will be given an outcome questionnaire, and will 
have their length of stay and other data will be censored at that point (i.e. it will be handled as the date 
of discharge); the fact of censoring will be noted. 
 
8. INTERVENTIONS  
 
One pack containing an eye mask and earplugs. Supplier: Delmore LTD.  It will be kept in a patient 
labelled clear plastic pouch. It will contain minimal instructions on their use.  Patients will be allowed to 
take them home when they leave. 
9. SAFETY REPORTING  
9.1. Definition of Serious Adverse Events 


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A serious adverse event is any untoward medical occurrence that: 
• 
results in death 
• 
is life-threatening 
• 
requires inpatient hospitalisation or prolongation of existing hospitalisation 
• 
results in persistent or significant disability/incapacity 
• 
consists of a congenital anomaly or birth defect. 
 
Other ‘important medical events’ may also be considered serious if they jeopardise the participant or 
require an intervention to prevent one of the above consequences. 
NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the 
participant was at risk of death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were more severe. 
It is anticipated that patients will experience many events.  With the exception of falls and deaths these 
will not be recorded because the likelihood of the intervention causing serious harm is considered very 
small, and collecting the data would be excessively burdensome and unjustified. 
9.2. Reporting Procedures for Serious Adverse Events 
A serious adverse event (SAE) occurring to a participant should be reported to the REC that gave a 
favourable opinion of the study where in the opinion of the Chief Investigator the event was ‘related’ 
(resulted from administration of any of the research procedures) and ‘unexpected’ in relation to those 
procedures. Reports of related and unexpected SAEs should be submitted within 15 working days of the 
Chief Investigator becoming aware of the event, using the HRA report of serious adverse event form (see 
HRA website). 
All SAEs (other than those defined in the protocol as not requiring reporting) must be reported on the 
Oxford University Hospitals NHS Trust SAE reporting form to OUH study team within 24 hours of the Site 
Study Team becoming aware of the event by email or fax. 
In the unlikely event that a Serious Adverse Event is identified, it will be reported to the R&D office 
immediately. SAE reports should be faxed or emailed to: (01865) 572242 or ouhsae.reports@nhs.net 
All SAE information must be recorded on an SAE form and faxed, or scanned and emailed, to R&D.  
Additional and further requested information (follow-up or corrections to the original case) will be 
detailed on a new SAE Report Form and faxed/emailed to R&D. 
10. STATISTICS AND ANALYSIS 
 
All data will be entered onto a secure computer database, with no patient-identifiable data.  The patient 
registration number given will be used. 
 


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10.1. 
Description of Statistical Methods 
There will be no interim analysis. 
The primary analyses will be to compare the two groups on all items collected, using t-test and Mann-
Whitney U tests as appropriate with two-tailed testing (i.e. accepting that harm is also possible).  The 
expectation is that the intervention group will have: 
• 
Better sleep on the questionnaire  
• 
Less use of night sedation over their hospital stay 
• 
Less falls over their hospital stay 
• 
A shorter length of stay 
 
Secondary analyses will investigate: 
• 
Variation between wards on all measures, irrespective of patient group. 
• 
Reported use of and problems with the earplugs and eye masks. 
10.2. 
The Number of Participants 
There is no data to allow sample size calculation, nor are there data on recruitment and loss of patients.  
We estimate that it should be possible to recruit a total of 400 patients, which should be sufficient to 
detect any worthwhile benefit. 
10.3. 
Analysis of Outcome Measures 
All participant data will be used excluding those that withdrew consent or did not complete the study 
questionnaire. 
11. DATA MANAGEMENT 
11.1. 
Access to Data 
Direct access will be granted to authorised representatives from the Sponsor or host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. 
11.2. 
Data Recording and Record Keeping 
Hard copies of data (consent forms and SleepSure questionnaire) will be kept in a locked filing cabinet in 
a secure hospital location. The SleepSure research nurse and the SleepSure team will have access to this 
data. 
 
Electronic data will be kept in the form of the participant ID log and excel database. The participant ID 
log will be a password-protected document where the MRN of the patient and the anonymous patient ID 
will be stored, this will be completed when the anonymous ID is allocated upon recruitment. This will be 
in a different location to the excel database. They will both be kept in a secure location on the trust 


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network accessed by a password-protected computer. The SleepSure nurse and the SleepSure team will 
have access to this data. 
Personal information i.e. the Participant ID log will be destroyed within 3 months after the study has 
ended.  
As per Oxford University Hospital NHS Foundation Trust's policy both electronic and hard copy data will 
be kept for a minimum of 5 years after the study period. The anonymised electronic database will 
continue to be stored in a secure location on the Trust intranet. Once the data collection period is 
complete the hard copy data will be kept in a locked filing cabinet in the Oxford Centre of Enablement 
offices (place of work of the Chief Investigator).  During this period only members of the SleepSure team 
will have access to this data. At the time of destruction (estimation 5 years) the hard copies will be 
destroyed as per Trust guidelines. 
12. QUALITY ASSURANCE PROCEDURES 
 
The study will be monitored via the study amendments and end of study report. The study may be 
monitored or audited in accordance with the current approved protocol, ICH GCP, relevant regulations 
and standard operating procedures. 
13. ETHICAL AND REGULATORY CONSIDERATIONS 
13.1. 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki. 
13.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. 
13.3. 
Approvals 
The protocol, informed consent form, participant information sheet and any proposed advertising 
material will be submitted to an appropriate Research Ethics Committee (REC), and host institution(s) for 
written approval. 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
13.4. 
Reporting 
The CI shall submit once a year throughout the study, or on request, an Annual Progress report to the 
REC Committee, host organisation and Sponsor.  In addition, an End of Study notification and final report 
will be submitted to the same parties. 


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13.5. 
Participant Confidentiality 
The study staff will ensure that the participants’ anonymity is maintained. All documents will be stored 
securely and only accessible by study staff and authorised personnel. The study will comply with the Data 
Protection Act, which requires data to be anonymised as soon as it is practical to do so. This will occur at 
patient recruitment when they will be assigned an anonymous ID number. The participants will from 
then on be identified only by a participants ID number on the electronic excel database as well as on the 
SleepSure questionnaire.   
13.6. 
Expenses and Benefits 
No expenses will be paid (none will arise), but patients in the intervention group may keep the 
equipment if they wish. 
13.7. 
Other Ethical Considerations 
Patient who cannot apply the eye masks and earplugs for themselves will not be included.The only 
ethical and practical issue is what could or should be offered to controls in order to balance expectation 
bias.  Information leaflets on sleep could be considered.  On balance it seems best to offer nothing. If the 
study shows benefit then a trial of information leaflets against earplugs/eye masks could be undertaken 
to determine effect of expectation. 
14. FINANCE AND INSURANCE 
14.1. 
Funding 
£10,500 awarded by Challenge 2023.  
14.2. 
Insurance 
NHS bodies are legally liable for the negligent acts and omissions of their employees. If you are harmed 
whilst taking part in a clinical research study as a result of negligence on the part of a member of the 
study team this liability cover would apply. 
Non-negligent harm is not covered by the NHS indemnity scheme. Therefore Oxford University Hospitals 
NHS Foundation Trust cannot agree in advance to pay compensation. 
In exceptional circumstances an ex-gratia payment may be offered. 
15. PUBLICATION POLICY 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study.  Authors will acknowledge that Challenge 2023 funded the 
study. Authorship will be determined in accordance with the ICMJE guidelines and other contributors will 
be acknowledged. 
 


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16. REFERENCES 
 
1. Care and Quality Comission. National findings from the 2013 Inpatients survey. London, United 
Kingdom; 2014 p. 5.  
2. Weinhouse G, Schwab R, Watson P, Patil N, Vaccaro B, Pandharipande P et al. Bench-to-bedside 
review: Delirium in ICU patients - importance of sleep deprivation. Critical Care. 2009;13(6):234.  
3. Dündar Y, Boland A, Strobl J, Dodd S, Haycox A, Bagust A et al. Newer hypnotic drugs for the short-
term management of insomnia: a systematic review and economic evaluation. Health Technol Assess. 
2004;8(24).  
4. Joint Formulary Committee. British National Formulary. BMJ Publishing Group Ltd and Pharmaceutical 
Press; 2014.  
5. National Institute for Health & Care Excellence. CG103: Delirium: Diagnosis, prevention and 
management. London, United Kingdom; 2010.  
6. Department of Health. Reference costs 2013-14 (National Health Service). London; 2014 p. 5.  
7. Koslowsky M, Babkoff H. Meta-Analysis of the Relationship Between Total Sleep Deprivation and 
Performance. Chronobiology International. 1992;9(2):132-136.  
8. Pitcher J, Huffcutt A. Effects of sleep deprivation on performance: A meta-analysis. Sleep: Journal of 
Sleep Research & Sleep Medicine [Internet]. 1996 [cited 2 April 2015];19(4). Available from: 
http://psycnet.apa.org/psycinfo/1997-07865-006 
9. Hu R, Jiang X, Zeng Y, Chen X, Zhang Y. Effects of earplugs and eye masks on nocturnal sleep, 
melatonin and cortisol in a simulated intensive care unit environment. Critical Care. 2010;14(2):R66.  
10. Le Guen M, Nicolas-Robin A, Lebard C, Arnulf I, Langeron O. Earplugs and eye masks vs routine care 
prevent sleep impairment in post-anaesthesia care unit: a randomized study. British Journal of 
Anaesthesia. 2013;112(1):89-95.  
11. Scotto C, McClusky C, Spillan S, Kimmel J. Earplugs improve patients’ subjective experience of sleep in 
critical care. Nursing in Critical Care. 2009;14(4):180-184.  
12. Van Rompaey B, Elseviers M, Van Drom W, Fromont V, Jorens P. The effect of earplugs during the 
night on the onset of delirium and sleep perception: a randomized controlled trial in intensive care 
patients. Critical Care. 2012;16(3):R73.