Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

NCT01284140 | Completed Results DMC

• 2 other identifiers: 2011057545K23HL088020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Critical Illness; Sleep Deprivation; Respiratory Failure; Sleep Disorders, Circadian Rhythm

Keywords

Critical illness; Sleep; Polysomnography; Respiratory failure; Circadian rhythm; Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Normal Circadian Timing

  Day 3

• Circadian Amplitude

  Day 3

• Spectral Edge Frequency 95%

  Day 2

• Delirium

  Day 3

Study Arms (2)

Sleep promotion protocol

EXPERIMENTAL

Behavioral: 48 hours of sleep and circadian rhythm promotion including timed light exposure.

Behavioral: Sleep and circadian rhythm promotion

Usual care

ACTIVE COMPARATOR

Behavioral: 48 hours of usual care.

Behavioral: Usual care

Interventions

Sleep and circadian rhythm promotion BEHAVIORAL

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.

Sleep promotion protocol

Usual care BEHAVIORAL

Usual care.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Receiving mechanical ventilation and intravenous sedation

You may not qualify if:

• 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

Sponsors & Collaborators

• Brian Gehlbach: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Critical Illness; Sleep Deprivation; Respiratory Insufficiency; Sleep Disorders, Circadian Rhythm

Interventions

Sleep

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Chronobiology Disorders; Occupational Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Lower dose light intervention received by one subject; the study design resulted in significant attrition, limiting the number of evaluable patients; baseline differences in the timing of maximal melatonin excretion may have influenced the results.

Results Point of Contact

• Title: Brian K. Gehlbach, MD
• Organization: University of Iowa

brian-gehlbach@uiowa.edu

319-356-3603

Study Officials

• Brian K Gehlbach, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 7, 2018
• Results First Posted: May 7, 2018

Record last verified: 2018-05

Locations

US (2)