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Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01681043
Enrollment
19
Registered
2012-09-07
Start date
2012-09-30
Completion date
2013-12-31
Last updated
2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

Sleep

Brief summary

Sleep investigation in respirator treated ICU patients: the importance of intensive environment. Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and increased mortality. The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise, light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep quality in respirator treated ICU patients. Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc. AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m. after randomization.

Interventions

BEHAVIORALprotocol 'Quiet in the room'

Protocol 'Quite in the room' between 10 p.m. and 6 a.m. * nurse nearby * no visits after 10 p.m. * decreased alarm sound in ventilator and monitor * decreased light intensity * no unnecessary conversations around the patient * medication should be limited to max 1-2 times in this time period * no unnecessary therapeutic or diagnostic procedures in this time period * earplugs and sleep masks

Sponsors

Vejle Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* awake and relevant respirator treated patients with expected 2 or more respirator dags

Exclusion criteria

* GCS \< 11 * cerebral hemorrhage or infarction during the current hospitalization * delirium * inotropes and/or vasopressors

Design outcomes

Primary

MeasureTime frameDescription
the number of arousalsper hour of sleeparousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted

Secondary

MeasureTime frameDescription
total sleep time24 hourstotal sleep time during 24 hour period
N1 sleep24 hoursN1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted
N2 sleep24 hoursN2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted
N3 sleep24 hoursN3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted
REM sleep24 hoursREM sleep will be scored during sleep periods and the percent of REM sleep will be counted

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026