Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit

NCT02997839 | Terminated

• 1 other identifier: IRB00092868
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The role of sleep in patients admitted to the intensive care unit is an emerging field of research. There have been studies that show patients in the ICU have poor sleep including sleep fragmentation, multiple arousals, decreased stage 3 sleep and reduced REM sleep (1, 2, 3). Causes of poor sleep in the ICU include severity of illness, abnormal light exposure, and frequent arousals for medical care. Not only does poor sleep contribute to reduced cognitive function and delirium, but there are also implications for the immune system function and wound healing (4). Polysomnography is regarded as the gold standard for sleep studies, however it has limited utility in the ICU population (5) and alternative methods of sleep analysis need to be investigated to better understand the underlying physiologic mechanisms and subsequent cognitive effects.

Conditions

Sleep Fragmentation

Outcome Measures

Primary Outcomes (1)

• Detect the effects of disrupted sleep with quantitative EEG analysis

  The investigators will use an automated EEG detection system used in patients with continuous EEG (cEEG) monitoring to detect duration of sleep related EEG brain activity, number of intervals of activation, and the duration of the intervals for sleep activities including: REM, Stage 1, stage 2, and stage 3 sleep, sleep spindles, and alpha activity.

  Up to 12 hours

Secondary Outcomes (3)

• Precision, accuracy and bias of the automated cEEG algorithm by comparing it to the interpretations of sleep trained neurologists

  Up to 4 hours

• Subjective measure of sleep assessment using the Richards-Campbell Sleep Questionnaire

  Up to 12 hours

• Quantitative assessment of alertness using a psychomotor vigilance task (PVT).

  Up to 12 hours

Study Arms (2)

group 2

NO INTERVENTION

no intervention

group 1

OTHER

sleep disruption

Behavioral: sleep disruption

Interventions

sleep disruption BEHAVIORAL

Group two will have interrupted sleep at time periods of 2 hours post operatively. Group two will be woken every 2 hours, which is the standard NCCU protocol.

Also known as: group 2

group 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post operative back patients in the NCCU with no history of brain injury

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Paul A Nyquist, MD

  Johns Hopkins school of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)