Gabapentin for Sleep Disruption in Critical Illness

Recruiting in Palo Alto (17 mi)

Overseen byAndrea Tsai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Tufts Medical Center

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Sleep disruption in the intensive care unit (ICU) is a common comorbidity associated with patient morbidity and distress. There are no recommended pharmacologic interventions for sleep promotion, and many pharmacologic solutions may actually increase the risk of adverse outcomes rather than impart benefits. Gabapentin, an anticonvulsant with applications in neuropathic pain, has been investigated for sleep promotion in various populations of outpatients. Here investigators propose a pilot study of gabapentin as a therapy for sleep disruption in the ICU. Outcomes measured will be sleep quality as measured by RCSQ (Richards-Campbell Sleep Questionnaire), wrist actigraphy, EEG, and BIS monitoring. The goal is to enroll 80 critically ill patients, 40 intubated and 40 non-intubated patients. The study will take place over 2 nights, with baseline sleep measurements occurring on the first night and gabapentin administration with repeat sleep measurements on the second night.

Eligibility Criteria

This trial is for adults over 18 in the ICU or step-down unit with a risk of delirium, expected to stay at least another 48 hours. It's not for comatose patients, those with severe brain conditions, pregnant women, prisoners, anyone too unstable for research, recent gabapentin users, those needing frequent neuro checks or with very poor kidney function.

Inclusion Criteria

I expect to stay in intensive care or a similar unit for at least 48 hours after joining.

I am over 60 or have other risk factors for confusion after surgery.

My goal is to be calm but awake.

+2 more

Exclusion Criteria

Pregnant women

You are very sick and expected to pass away in the next day.

You are allergic or have had a bad reaction to gabapentin.

+9 more

Participant Groups

The study tests if Gabapentin (a drug used for seizures and nerve pain) can help improve sleep in critically ill patients. The effect on sleep quality will be measured using questionnaires and monitoring devices over two nights: one without the drug and one after taking it.

1Treatment groups

Experimental Treatment

Group I: Critically ill patientsExperimental Treatment1 Intervention

Administer gabapentin 300 mg PO at 8 PM for sleep

Gabapentin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Neurontin for: