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NCT03247062
Sleep Bundle for Improving Sleep in ICU Patients
NA trial testing Quality improvement - sleep bundle in Sleep in 130 participants. Status unknown.
28 February 2018
Quick facts
| Lead sponsor | University Hospital, Geneva |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 130 |
| Start date | 1 September 2017 |
| Primary completion | 28 February 2018 |
| Estimated completion | 31 August 2018 |
Drugs / interventions tested
- Quality improvement - sleep bundle
Conditions studied
- Sleep — all drugs for Sleep →
- Intensive Care Unit Syndrome — all drugs for Intensive Care Unit Syndrome →
Sponsor
University Hospital, Geneva
Who can join
17 and older, any sex, with Sleep or Intensive Care Unit Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Summary of the project : Lack or disturbances of sleep are major problems in patients staying in intensive care unit (ICU) due to the particular environment. The noises, lack of circadian rhythm of light lead to progressive deafferentation. The patients are then at risk of immune deficiencies, agitation and confusion states, cognitive troubles that may be associated to increased morbidity and mortality in the short and long term. Thus, improvement of the sleep of the ICU patients may impact non only during the ICU stay but also on their future quality of life. The sleep bundle project is a quality improvement project with a before-after design, consisting in the evaluation of a bundle of measures that may increase the quality and duration of sleep in ICU patients. The bundle consists in the proposition of eye-mask, ear-plugs, music and/or massage to the patients in parallele to structural and organizational modifications of the service such as the decrease of the alarms sounds, changing the luminosity between day and night, etc. The principal indicators followed will be: * The sleep quality of the patients * The continuous noise intensity in the rooms * The continuous light intensity in the rooms Baseline - before period: 8 weeks Implementation of the bundle with training of the team: 4 weeks After period: 8 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03247062
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03247062 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Geneva
- Last refreshed: 11 August 2017
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/NCT03247062.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing