Investigation of Sleep in the Intensive Care Unit

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Sleep deprivation is common and severe in critically ill patients cared for in intensive care units (ICUs), and is hypothesized to be a key modifiable risk factor for delirium and long-term cognitive disability. Dexmedetomidine reduces the incidence of delirium in ICU patients by unknown mechanisms. This project will determine whether dexmedetomidine reduces delirium by improving sleep, whether bolus dosing vs continuous infusion is better, and the relationship of sleep quality to long-term cognitive outcomes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Admitted to MGH Blake 7 or 12, or Elllison 4 ICU at Massachusetts General Hospital.

2. Male or female, aged > 50 years

3. Provision of signed and dated informed consent form (by patient or LAR)

4. Stated willingness to comply with all study procedures and availability for the duration of the study.

5. Not on mechanical ventilation at the time of enrollment.

6. Able to be enrolled before 7PM.

7. For females of reproductive potential: pregnancy test is negative.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unable to be assessed for delirium (e.g. blindness or deafness)

2. Pregnancy or lactation

3. Known allergic reactions to components of dexmedetomidine

4. Follow-up would be difficult (e.g. active substance abuse, homelessness)

5. Severe dementia, as measured by a score of ≥3.3 on the Short Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

6. Known pre-existing neurologic disease or injury with focal neurologic or cognitive deficits

7. Serious cardiac disease (e.g. sick sinus syndrome, sinus bradycardia, second or third degree AV block, congestive heart failure with ejection fraction < 30%)

8. Severe liver dysfunction (Child-Pugh class C)

9. Severe renal dysfunction (receiving dialysis)

10. Low likelihood of survival >24 hours

11. Low likelihood of staying in ICU overnight

12. Patient is receiving either of the anticholinergic drugs scopolamine or penehyclidine

13. Concomitant enrollment in another study protocol that may interfere with data acquisition or reliability of measurements;

14. 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.