Status:
COMPLETED
Investigation of Sleep in the Intensive Care Unit
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Delirium
Sleep
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Sleep deprivation is common and often severe in critically ill patients cared for in intensive care units (ICUs) and is hypothesized to be a modifiable risk factor for delirium, which in turn is hypot...
Detailed Description
Sleep deprivation is among the most common complaints about the ICU experience. ICU sleep tends to be light and non-restorative (as opposed to deep/restorative sleep), severely fragmented, and distrib...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Admitted or scheduled to be admitted to an MGH medical or surgical ICU (Blake 7 or 12, or Ellison 4)
- Male or female, aged ≥ 50 years
- Provision of signed and dated informed consent form (by patient or legally authorized representative (LAR))
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Not on mechanical ventilation at the time of enrollment
- Able to be enrolled before 7PM
- For females of reproductive potential: pregnancy test is negative
- Exclusion Criteria
- Dementia, as measured by a score of ≥3.3 on the Informant Questionnaire on Cognitive Decline in the Elderly Short Form (IQCODE-SF)
- Unable to be assessed for delirium (e.g. blindness or deafness)
- Follow-up would be difficult (e.g. active substance abuse, homelessness)
- Pregnancy or lactation
- Known pre-existing neurologic disease or injury with focal neurologic or cognitive deficits
- Serious cardiac disease (e.g. sick sinus syndrome without a pacemaker, sinus bradycardia, second- or third-degree AV block, congestive heart failure with ejection fraction \<30%)
- Severe liver dysfunction (Child-Pugh class C)
- Severe renal dysfunction (receiving dialysis)
- Low likelihood of survival \>24 hours
- Low likelihood of staying in ICU overnight
- Known allergic reactions to components of dexmedetomidine
- Patient is receiving or planning to go on dexmedetomidine at the time of enrollment
- Patient is receiving either of the anticholinergic drugs scopolamine or penehyclidine; or alpha-2-agonist clonidine
- Concomitant enrollment in another study protocol that may interfere with data acquisition or reliability of measurements
- Deemed unsuitable for selection by the research team or ICU providers due to any medical, legal, social, language (non-English speaking) or interpersonal issues that would either compromise the study or the routine care of patients
Exclusion
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT03355053
Start Date
May 29 2018
End Date
March 24 2023
Last Update
October 8 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114