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

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Behavioral: protocol 'Quiet in the room'

• Registration Number: NCT01681043
• Lead Sponsor: Vejle Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-23
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
24 hours PSG under protocol 'Quiet in the room'	protocol 'Quiet in the room'	24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.

Primary Outcome Measures

Name	Time	Method
the number of arousals	per hour of sleep	arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted

Secondary Outcome Measures

Name	Time	Method
total sleep time	24 hours	total sleep time during 24 hour period
N1 sleep	24 hours	N1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted
N2 sleep	24 hours	N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted
N3 sleep	24 hours	N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted
REM sleep	24 hours	REM sleep will be scored during sleep periods and the percent of REM sleep will be counted

Trial Locations

Locations (1)

Department of Anaesthesia and Intensive Care, Vejle Hospital; 🇩🇰 Vejle, Denmark