← Back to Search

Alpha-2 Adrenergic Agonist

Dexmedetomidine (Dex) very-low dose group for Sleep (ICU-SLEEP Trial)

Phase 2
Waitlist Available
Led By M. Brandon Westover, MD/PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

ICU-SLEEP Trial Summary

This trial will test whether dexmedetomidine reduces delirium by improving sleep in ICU patients, and will compare the effects of bolus dosing vs continuous infusion.

Eligible Conditions
  • Sleep
  • Delirium

ICU-SLEEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of delirium
Secondary outcome measures
Incidence of delirium between Dex groups

ICU-SLEEP Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Dexmedetomidine (Dex) very-low dose groupActive Control1 Intervention
Study drug will be administered by the patient's nurse. Study drugs (50 mL of 4 ug/ ml dexmedetomidine hydrochloride or 50 ml normal saline (NS)) will be provided as clear solutions in identical 60 mL syringes. In each study arm patients will receive a continuous overnight infusion of study drug (Dex or placebo) at 0.075 ml/kg/h Dex or NS from 8PM until 7AM, for 7 consecutive nights or until leaving the ICU, depending on randomization group, as follows: 1) Group 1: Dex at 0.1 mcg/kg/h from 8PM until 7AM
Group II: Dexmedetomidine (Dex) low dose groupActive Control1 Intervention
Study drug will be administered by the patient's nurse. Study drugs (50 mL of 4 ug/ ml dexmedetomidine hydrochloride or 50 ml normal saline (NS)) will be provided as clear solutions in identical 60 mL syringes. In each study arm patients will receive a continuous overnight infusion of study drug (Dex or placebo) at 0.075 ml/kg/h Dex or NS from 8PM until 7AM, for 7 consecutive nights or until leaving the ICU, depending on randomization group, as follows: 2) Group 2: NS at 0.3 mcg/kg/h from 8PM until 7AM
Group III: Usual care + placebo groupPlacebo Group1 Intervention
Study drug will be administered by the patient's nurse. Study drugs (50 mL of 4 ug/ ml dexmedetomidine hydrochloride or 50 ml normal saline (NS)) will be provided as clear solutions in identical 60 mL syringes. In each study arm patients will receive a continuous overnight infusion of study drug (Dex or placebo) at 0.075 ml/kg/h Dex or NS from 8PM until 7AM, for 7 consecutive nights or until leaving the ICU, depending on randomization group, as follows: 3) Group 3: NS at 0.075 ml/kg/h from 8PM until 7AM.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,197,605 Total Patients Enrolled
11 Trials studying Sleep
13,763 Patients Enrolled for Sleep
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
648,640 Total Patients Enrolled
1 Trials studying Sleep
56 Patients Enrolled for Sleep
M. Brandon Westover, MD/PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
26 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment offer opportunities for volunteers at the moment?

"Affirmative. According to the information found on clinicaltrials.gov, this experimental trial is actively seeking participants. This research was first posted on June 1st 2018 and has been revised as recently as March 18th 2021. A total of 750 patients need to be enrolled across a single medical centre."

Answered by AI

To what conditions is a low dose of Dexmedetomidine generally administered?

"Dexmedetomidine (Dex) in low doses can be employed to address ailments like mechanical ventilation, disease, and cyclic vomiting syndrome."

Answered by AI

What is the upper-limit of enrollees for this clinical trial?

"Affirmative. The clinicaltrial.gov website is conveying that this medical research project, posted on June 1st 2018 and last modified March 18th 2021, is actively searching for participants. A total of 750 patients need to be enrolled from a single site."

Answered by AI

What potential detrimental effects may be posed by the administration of a low dose of Dexmedetomidine?

"Due to the lack of data supporting efficacy and some safety data, our team has rated Dexmedetomidine (Dex) low dose group a 2 on a scale from 1 to 3."

Answered by AI

What prior experiments involving a small dose of Dexmedetomidine (Dex) have been conducted?

"Currently, there are 110 studies actively exploring the effects of Dexmedetomidine (Dex) low dose group, with 23 trials in Phase 3. Of those locations conducting clinical research into this drug, 207 can be located around Karachi, Sindh."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Investigation of Sleep in the Intensive Care Unit
Michael Brandon Westover 2018. "Investigation of Sleep in the Intensive Care Unit". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03355053.
~110 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top