Trial Outcomes & Findings for SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep (NCT NCT02732912)
NCT ID: NCT02732912
Last Updated: 2019-10-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
206 participants
Primary outcome timeframe
At end of first night in hospital after recruitment (i.e. the next morning)
Results posted on
2019-10-01
Participant Flow
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)
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
109
|
|
Overall Study
COMPLETED
|
87
|
91
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
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
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=97 Participants
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
|
Eye Mask and Ear Plugs
n=109 Participants
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
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
n=97 Participants
|
48.4 years
n=109 Participants
|
51.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=97 Participants
|
70 Participants
n=109 Participants
|
121 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=97 Participants
|
39 Participants
n=109 Participants
|
85 Participants
n=206 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
97 participants
n=97 Participants
|
109 participants
n=109 Participants
|
206 participants
n=206 Participants
|
|
Ward type
Surgical wards
|
53 Participants
n=97 Participants
|
54 Participants
n=109 Participants
|
107 Participants
n=206 Participants
|
|
Ward type
Neuroscience
|
21 Participants
n=97 Participants
|
21 Participants
n=109 Participants
|
42 Participants
n=206 Participants
|
|
Ward type
Gynaecology
|
14 Participants
n=97 Participants
|
26 Participants
n=109 Participants
|
40 Participants
n=206 Participants
|
|
Ward type
Acute medical
|
5 Participants
n=97 Participants
|
6 Participants
n=109 Participants
|
11 Participants
n=206 Participants
|
|
Ward type
Geriatric
|
4 Participants
n=97 Participants
|
2 Participants
n=109 Participants
|
6 Participants
n=206 Participants
|
|
Night after admission
First night
|
6 Participants
n=97 Participants
|
4 Participants
n=109 Participants
|
10 Participants
n=206 Participants
|
|
Night after admission
Second night
|
41 Participants
n=97 Participants
|
52 Participants
n=109 Participants
|
93 Participants
n=206 Participants
|
|
Night after admission
Third night
|
9 Participants
n=97 Participants
|
16 Participants
n=109 Participants
|
25 Participants
n=206 Participants
|
|
Night after admission
Fourth night
|
12 Participants
n=97 Participants
|
7 Participants
n=109 Participants
|
19 Participants
n=206 Participants
|
|
Night after admission
Fifth night
|
8 Participants
n=97 Participants
|
6 Participants
n=109 Participants
|
14 Participants
n=206 Participants
|
|
Night after admission
sixth or later night
|
13 Participants
n=97 Participants
|
12 Participants
n=109 Participants
|
25 Participants
n=206 Participants
|
|
Night after admission
No data returned
|
6 Participants
n=97 Participants
|
9 Participants
n=109 Participants
|
15 Participants
n=206 Participants
|
|
Night after admission
Discharged before first night
|
2 Participants
n=97 Participants
|
3 Participants
n=109 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control
n=87 Participants
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
|
Eye Mask and Ear Plugs
n=91 Participants
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
|
|---|---|---|
|
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
|
6.33 units on a scale
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: From date of admission to date of discharge, up to 90 daysPopulation: 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.
Time in days from admission to discharge from hospital (not from ward). These data were derived from the hospital administration data-base.
Outcome measures
| Measure |
Control
n=97 Participants
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
|
Eye Mask and Ear Plugs
n=109 Participants
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
|
|---|---|---|
|
Length of Stay
|
4.83 days
Standard Deviation 6.21
|
3.67 days
Standard Deviation 3.71
|
SECONDARY outcome
Timeframe: From date of admission to date of discharge, up to 90 daysPopulation: 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.
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"
Outcome measures
| Measure |
Control
n=97 Participants
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
|
Eye Mask and Ear Plugs
n=109 Participants
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
|
|---|---|---|
|
Use of Zopiclone (Night Sedation)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From date of admission to date of discharge, up to 90 daysPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=97 Participants
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
|
Eye Mask and Ear Plugs
n=109 Participants
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
|
|---|---|---|
|
Number of Falls
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At end of first night in hospital (first morning in hospital)The SleepSure questionnaire asks about use of the intervention on the night before.
Outcome measures
| Measure |
Control
n=97 Participants
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
|
Eye Mask and Ear Plugs
n=109 Participants
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
|
|---|---|---|
|
Use of Intervention
Ear plugs AND eye masks
|
0 Participants
|
65 Participants
|
|
Use of Intervention
Ear plugs ONLY
|
1 Participants
|
1 Participants
|
|
Use of Intervention
Eye mask ONLY
|
1 Participants
|
13 Participants
|
|
Use of Intervention
Neither ear plug or mask
|
87 Participants
|
15 Participants
|
|
Use of Intervention
Unknown
|
8 Participants
|
15 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Eye Mask and Ear Plugs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place