Sleep
Conditions
Keywords
falls, sleep
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
Interventions
DEVICEEar plugs
The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.
DEVICEEye Mask
The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.
DRUGZopiclone
This night sedation will be given to any patient requesting it, in either group
Sponsors
Oxford University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Randomised, investigator-blinded, parallel group design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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)
Participants by arm
| Arm | Count |
|---|---|
| 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.
Zopiclone: This night sedation will be given to any patient requesting it, in either group | 97 |
| 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.
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 | 109 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharged before night | 2 | 6 |
| Overall Study | Incomplete completion of questionnaire | 2 | 3 |
| Overall Study | No outcome; discharged or refused | 6 | 9 |
Baseline characteristics
| Characteristic | Eye Mask and Ear Plugs | Control | Total |
|---|---|---|---|
| Age, Continuous | 48.4 years | 55.3 years | 51.6 years |
| Night after admission Discharged before first night | 3 Participants | 2 Participants | 5 Participants |
| Night after admission Fifth night | 6 Participants | 8 Participants | 14 Participants |
| Night after admission First night | 4 Participants | 6 Participants | 10 Participants |
| Night after admission Fourth night | 7 Participants | 12 Participants | 19 Participants |
| Night after admission No data returned | 9 Participants | 6 Participants | 15 Participants |
| Night after admission Second night | 52 Participants | 41 Participants | 93 Participants |
| Night after admission sixth or later night | 12 Participants | 13 Participants | 25 Participants |
| Night after admission Third night | 16 Participants | 9 Participants | 25 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 109 participants | 97 participants | 206 participants |
| Sex: Female, Male Female | 70 Participants | 51 Participants | 121 Participants |
| Sex: Female, Male Male | 39 Participants | 46 Participants | 85 Participants |
| Ward type Acute medical | 6 Participants | 5 Participants | 11 Participants |
| Ward type Geriatric | 2 Participants | 4 Participants | 6 Participants |
| Ward type Gynaecology | 26 Participants | 14 Participants | 40 Participants |
| Ward type Neuroscience | 21 Participants | 21 Participants | 42 Participants |
| Ward type Surgical wards | 54 Participants | 53 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 109 |
| other Total, other adverse events | 0 / 97 | 0 / 109 |
| serious Total, serious adverse events | 0 / 97 | 0 / 109 |
Outcome results
Primary
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).
Time frame: At end of first night in hospital after recruitment (i.e. the next morning)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids. | 5.09 units on a scale | Standard Deviation 2.05 |
| Eye Mask and Ear Plugs | SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids. | 6.33 units on a scale | Standard Deviation 2.13 |
Secondary
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.
Time frame: From date of admission to date of discharge, up to 90 days
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Length of Stay | 4.83 days | Standard Deviation 6.21 |
| Eye Mask and Ear Plugs | Length of Stay | 3.67 days | Standard Deviation 3.71 |
Secondary
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.
Time frame: From date of admission to date of discharge, up to 90 days
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Falls | 0 Participants |
| Eye Mask and Ear Plugs | Number of Falls | 0 Participants |
Secondary
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
Time frame: From date of admission to date of discharge, up to 90 days
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Use of Zopiclone (Night Sedation) | 2 Participants |
| Eye Mask and Ear Plugs | Use of Zopiclone (Night Sedation) | 3 Participants |
Other Pre-specified
Use of Intervention
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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Use of Intervention | Neither ear plug or mask | 87 Participants |
| Control | Use of Intervention | Unknown | 8 Participants |
| Control | Use of Intervention | Ear plugs AND eye masks | 0 Participants |
| Control | Use of Intervention | Ear plugs ONLY | 1 Participants |
| Control | Use of Intervention | Eye mask ONLY | 1 Participants |
| Eye Mask and Ear Plugs | Use of Intervention | Eye mask ONLY | 13 Participants |
| Eye Mask and Ear Plugs | Use of Intervention | Neither ear plug or mask | 15 Participants |
| Eye Mask and Ear Plugs | Use of Intervention | Ear plugs ONLY | 1 Participants |
| Eye Mask and Ear Plugs | Use of Intervention | Unknown | 15 Participants |
| Eye Mask and Ear Plugs | Use of Intervention | Ear plugs AND eye masks | 65 Participants |