CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 206 enrolled
Drug / intervention
Zopiclone +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Age ≥18 years
  • Expected hospital stay of at least one night
  • Able to understand and use earplugs and eye mask
  • Basic understanding of English reading and writing
Key exclusion· 2
  • Medical contraindication to earplugs or eye mask (e.g., eye infection)
  • Unlikely to benefit from intervention (e.g., deaf and blind individuals)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02732912
NCT02732912Phase 3Completed

SleepSure: A Randomised Controlled Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep

Oxford University Hospitals NHS Trust·interventional·Posted Apr 11, 2016·Updated Oct 1, 2019

In Brief

A Phase 3 clinical trial evaluating Ear plugs, Eye Mask, and 1 other intervention for Sleep. Completed, enrolled 206 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 11, 2016
Enrollment StartNov 25, 2016
Primary CompletionFeb 13, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.2 years ago

Interventions

Ear plugsdevice

The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.

Eye Maskdevice

The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.

Zopiclonedrug

This night sedation will be given to any patient requesting it, in either group