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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
Must not have
Gabapentin or pregabalin use in the last 7 days or at baseline
Age < 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 12 hours after gabapentin administration
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken gabapentin or pregabalin in the last week.
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I am under 18 years old.
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I require hourly checks for my brain function.
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My kidney function is very low or I need dialysis.
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I do not have severe brain conditions or injuries.
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My breathing support needs may change within a day of joining.
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I am currently taking sleep medication that is not a benzodiazepine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 12 hours after gabapentin administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and for 12 hours after gabapentin administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in sleep efficiency
Secondary study objectives
change in sleep quality
change in sleep quality: REM latency
change in sleep quality: sleep latency
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Critically ill patientsExperimental Treatment1 Intervention
Administer gabapentin 300 mg PO at 8 PM for sleep

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
263 Previous Clinical Trials
264,381 Total Patients Enrolled
Andrea Tsai, MDPrincipal InvestigatorTufts Medical Center

Media Library

Gabapentin (Anticonvulsant) Clinical Trial Eligibility Overview. Trial Name: NCT04631510 — Phase < 1
Sleep Disruption Research Study Groups: Critically ill patients
Sleep Disruption Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT04631510 — Phase < 1
Gabapentin (Anticonvulsant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04631510 — Phase < 1
~2 spots leftby Dec 2024
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