Trial · NCT02732912
SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
NCT02732912, Phase 3, Completed, Oxford University Hospitals NHS Trust; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep. Trials, record NCT02732912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02732912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
- NCT number
- NCT02732912
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 206 participants, actual
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Conditions
- Sleep
- Interventions
- Ear plugs, Eye Mask, Zopiclone
- First posted
- 2016-04-11
- Last updated
- 2019-10-01
- Results first posted
- 2019-10-01
- Limitations and caveats
- Less than 400 (target) recruited due to finances insufficient and delays in starting
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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" |
| Secondary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | units on a scale | MEAN | |
| SECONDARY | Length of Stay | From date of admission to date of discharge, up to 90 days | 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. | days | MEAN |
| SECONDARY | Use of Zopiclone (Night Sedation) | From date of admission to date of discharge, up to 90 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Falls | From date of admission to date of discharge, up to 90 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Use of Intervention | At end of first night in hospital (first morning in hospital) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids. | Control | 5.09 | Standard Deviation 2.05 | units on a scale | |
| SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids. | Eye Mask and Ear Plugs | 6.33 | Standard Deviation 2.13 | units on a scale | |
| Length of Stay | Control | 4.83 | Standard Deviation 6.21 | days | |
| Length of Stay | Eye Mask and Ear Plugs | 3.67 | Standard Deviation 3.71 | days | |
| Use of Zopiclone (Night Sedation) | Control | 2 | Participants | ||
| Use of Zopiclone (Night Sedation) | Eye Mask and Ear Plugs | 3 | Participants | ||
| Number of Falls | Control | 0 | Participants | ||
| Number of Falls | Eye Mask and Ear Plugs | 0 | Participants | ||
| Use of Intervention | Control | Ear plugs AND eye masks | 0 | Participants | |
| Use of Intervention | Eye Mask and Ear Plugs | Ear plugs AND eye masks | 65 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 97 | |
| Overall Study | STARTED | Eye Mask and Ear Plugs | 109 | |
| Overall Study | COMPLETED | Control | 87 | |
| Overall Study | COMPLETED | Eye Mask and Ear Plugs | 91 | |
| Overall Study | NOT COMPLETED | Control | 10 | |
| Overall Study | NOT COMPLETED | Eye Mask and Ear Plugs | 18 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | 0 | 97 |
| Total, all-cause mortality | Eye Mask and Ear Plugs | 0 | 109 |
| Total, other adverse events | Control | 0 | 97 |
| Total, other adverse events | Eye Mask and Ear Plugs | 0 | 109 |
| Total, serious adverse events | Control | 0 | 97 |
| Total, serious adverse events | Eye Mask and Ear Plugs | 0 | 109 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eye Mask and Ear Plugs vs Control: Use of Zopiclone (Night Sedation) | Trial comparisons |
| Eye Mask and Ear Plugs vs Control: Number of Falls | Trial comparisons |
| Eye Mask and Ear Plugs vs Control: deaths from any cause | Trial comparisons |
| Eye Mask and Ear Plugs vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02732912
GET https://conductscience.org/api/trials/v1/NCT02732912/registered