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

Study Overview
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Brief Summary
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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.

Conditions
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Sleep

Intervention / Treatment
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* Behavioral: protocol 'Quiet in the room'


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 24 hour PSG under ordinary conditions<br>24 hour PSG in 46 patients under ordinary (routine) conditions | |
| Active Comparator: 24 hours PSG under protocol 'Quiet in the room'<br>24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m. | Behavioral: protocol 'Quiet in the room'<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of arousals | arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted | per hour of sleep | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total sleep time | total sleep time during 24 hour period | 24 hours | 
| N1 sleep | N1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted | 24 hours | 
| N2 sleep | N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted | 24 hours | 
| N3 sleep | N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted | 24 hours | 
| REM sleep | REM sleep will be scored during sleep periods and the percent of REM sleep will be counted | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep