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Anticonvulsant
Gabapentin for Sleep Disruption in Critical Illness
Phase < 1
Waitlist Available
Led By Andrea Tsai, MD
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anticipated ICU or step-down unit length of stay ≥ 48 hours past time of enrollment
Riker score goal of 3 or 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 12 hours after gabapentin administration
Awards & highlights
Study Summary
This trial will investigate whether the drug gabapentin can help improve sleep for people in the ICU.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Gabapentin may cause dizziness, fatigue, coordination problems or swelling in limbs. In an ICU setting where patients are already critically ill, close monitoring will ensure any side effects are managed promptly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I expect to stay in intensive care or a similar unit for at least 48 hours after joining.
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My goal is to be calm but awake.
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I was in the ICU or a similar care unit for at least 24 hours.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 12 hours after gabapentin administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 12 hours after gabapentin administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in sleep efficiency
Secondary outcome measures
change in sleep quality
change in sleep quality: REM latency
change in sleep quality: sleep latency
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Critically ill patientsExperimental Treatment1 Intervention
Administer gabapentin 300 mg PO at 8 PM for sleep
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Who is running the clinical trial?
Tufts Medical CenterLead Sponsor
252 Previous Clinical Trials
252,918 Total Patients Enrolled
Andrea Tsai, MDPrincipal InvestigatorTufts Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are very sick and expected to pass away in the next day.You are allergic or have had a bad reaction to gabapentin.I have taken gabapentin or pregabalin in the last week.I am under 18 years old.I expect to stay in intensive care or a similar unit for at least 48 hours after joining.I require hourly checks for my brain function.I am over 60 or have other risk factors for confusion after surgery.My goal is to be calm but awake.I was in the ICU or a similar care unit for at least 24 hours.My kidney function is very low or I need dialysis.I am 18 years old or older.I do not have severe brain conditions or injuries.My breathing support needs may change within a day of joining.I am currently taking sleep medication that is not a benzodiazepine.
Research Study Groups:
This trial has the following groups:- Group 1: Critically ill patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is Gabapentin 300 mg PO at 8 PM used to target specifically?
"Gabapentin 300 mg PO can be taken at 8 PM to help with neuralgia, epilepsies, and postherpetic neuralgia."
Answered by AI
Are there other instances where Gabapentin 300 mg PO at 8 PM has been studied?
"There are 28 ongoing clinical trials for Gabapentin 300 mg PO at 8 PM. 11 of those trials are in Phase 3. While a majority of the studies are based in Columbus, Ohio, there are 71 locations running studies for this treatment."
Answered by AI
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