Gabapentin for Sleep in Critically Ill Patients (NCT04631510) | Clinical Trial Compass
CompletedEarly Phase 1
Gabapentin for Sleep in Critically Ill Patients
United States80 participantsStarted 2020-12-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Admitted to the ICU or step-down unit (neurologic intermediate care center or Pratt 8) for ≥ 24 hours
. ≥ 1 risk factor for delirium: benzodiazepine use, blood transfusions, age \>60 years, dementia, prior coma, pre-ICU emergency surgery or trauma, American Society of Anesthesia (ASA) score \> 3, Acute Physiology and Chronic Health Evaluation II (APACHE II) \>12, admission because of a neurologic disease, trauma, and the use of psychoactive medication (e.g., antipsychotics, anticonvulsants)
. Age ≥ 18 years old
. Anticipated ICU or step-down unit length of stay ≥ 48 hours past time of enrollment
. Riker score goal of 3 or 4
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in sleep efficiency
Timeframe: for 12 hours after gabapentin administration
. Patients who were considered by their primary physician to be too unstable to undergo this investigation
. Comatose patients or patients with severe debilitating neurologic disease such as cerebrovascular accidents, intracranial hemorrhage, subdural hematoma, intracranial primary or secondary cancers, or anoxic-hypoxic encephalopathy
. Moribund patient expected to die within 24 hours
. Expected change in intubation status within 24 hours of enrollment
. Gabapentin or pregabalin use in the last 7 days or at baseline