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

Sleep Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681043
• Other study ID #: S-20120001
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: March 24, 2015
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Regional Scientific Ethical Committee for Southern Denmark: Denmark
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• protocol '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

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia and Intensive Care, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	total sleep time	total sleep time during 24 hour period	24 hours	No
Secondary	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	No
Secondary	N2 sleep	N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted	24 hours	No
Secondary	N3 sleep	N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted	24 hours	No
Secondary	REM sleep	REM sleep will be scored during sleep periods and the percent of REM sleep will be counted	24 hours	No