Phase 3
N=206
SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
Sleep
Bottom Line
View on ClinicalTrials.gov: NCT02732912 ↗Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids. — 5.09; 6.33 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ear plugs (Device); Eye Mask (Device); Zopiclone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oxford University Hospitals NHS Trust
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids. |
5.09; 6.33 | — |
| SECONDARY Length of Stay |
4.83; 3.67 | — |
| SECONDARY Use of Zopiclone (Night Sedation) |
2; 3 | — |
| SECONDARY Number of Falls |
0; 0 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02732912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.