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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01284140
Other study ID # 201105754
Secondary ID 5K23HL088020
Status Completed
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date December 2016

Study information

Verified date May 2018
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.


Description:

Nearly 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This project is designed to characterize sleep and circadian rhythmicity in critically ill patients and to explore the efficacy of a non-pharmacological intervention to improve sleep and normalize circadian phase. The study will examine the effect of a protocol employing noise reduction and enforcement of a robust light-dark cycle on sleep quality and circadian rhythmicity. A secondary analysis will examine the relationship between delirium and sleep disruption and loss of circadian rhythmicity. Circadian rhythmicity will be characterized through the measurement of urinary 6-sulfatoxymelatonin levels at frequent intervals, while sleep will be assessed using continuous polysomnography.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years or older

- Receiving mechanical ventilation and intravenous sedation

Exclusion Criteria:

- Debilitating central nervous system disease or degenerative disorder

- Active seizures

- Persistent coma

- Renal failure requiring dialysis

- Expected to be extubated within 24 hours

- Currently receiving neuromuscular blocker

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep and circadian rhythm promotion
This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study.
Usual care
Usual care.

Locations

Country Name City State
United States University of Chicago Medical Center Chicago Illinois
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (2)

Lead Sponsor Collaborator
Brian Gehlbach National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Circadian Timing The magnitude of the phase change in 6-sulfatoxymelatonin excretion between Day 1 and Day 3 will be compared between the intervention and usual care groups. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1). Day 1 to Day 3
Secondary Normal Circadian Timing The percentage of subjects who exhibit normal circadian timing of 6-sulfatoxymelatonin excretion on Day 3 will be compared between the intervention and usual care groups. Day 3
Secondary Circadian Amplitude The amplitude (e.g. one half the value from peak to trough of the fitted cosine curve) of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups. Day 3
Secondary Spectral Edge Frequency 95% The difference between the polysomnographically derived daytime and nocturnal spectral edge frequency 95% parameter will be used as a measure of increased diurnal sleep/wake activity. This parameter will be compared between the usual care and intervention groups. Day 2
Secondary Delirium The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups. Day 3
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