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Optimized Sleep After Brain Injury: Sleep Hygiene Intervention After Traumatic Brain Injury

NCT02838082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-08-02

No results posted yet for this study

Summary

OSABI is a pilot study of a sleep hygiene protocol for sleep disruptions associated with TBI during inpatient rehabilitation. Twenty participants will be allocated (by minimization) either into a standard of care protocol or a sleep hygiene protocol for 4 weeks. Sleep efficiency (via actigraphy), post traumatic amnesia (OLOG), agitation (Agitated Behavior Scale) and cognitive function (Confusion Assessment Protocol) will be monitored during the trial period to examine relationships among them.

Conditions

Interventions

BEHAVIORAL

Sleep Hygiene Protocol

Sleep Hygiene Protocol involving 1) Improved sleep environment 2) Enhanced Circadian Stimuli 3) Increased Daytime Activation (blue light therapy, daytime light exposure and daytime sleep restriction) 4) Adjusted morning ADL routines and 5) Restricted Caffeine intake

BEHAVIORAL

Standard of Care

All standard of care procedures in a specialized traumatic brain injury inpatient rehabilitation unit

Sponsors & Collaborators

  • Colorado Traumatic Brain Injury Trust Fund

    collaborator OTHER

  • Craig Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02838082 on ClinicalTrials.gov