18 and older, any sex, with Sleep. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids.Primary· 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).
Group
Value
95% CI
Control
5.09
± 2.05
Eye Mask and Ear Plugs
6.33
± 2.13
Length of StaySecondary· 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.
Group
Value
95% CI
Control
4.83
± 6.21
Eye Mask and Ear Plugs
3.67
± 3.71
Use of Zopiclone (Night Sedation)Secondary· 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"
Group
Value
95% CI
Control
2
Eye Mask and Ear Plugs
3
Number of FallsSecondary· 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.
Group
Value
95% CI
Control
0
Eye Mask and Ear Plugs
0
Use of InterventionSecondary· At end of first night in hospital (first morning in hospital)
The SleepSure questionnaire asks about use of the intervention on the night before.
Group
Value
95% CI
Control
0
Eye Mask and Ear Plugs
65
Control
1
Eye Mask and Ear Plugs
1
Control
1
Eye Mask and Ear Plugs
13
Control
87
Eye Mask and Ear Plugs
15
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oxford University Hospitals NHS Trust
Last refreshed: 1 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02732912.