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Gabapentin for Sleep in Critically Ill Patients

NCT04631510 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-05

No results posted yet for this study

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.

Conditions

  • Intensive Care Unit Sleep Disruption

Interventions

DRUG

Gabapentin 300 mg PO at 8 PM

Administer gabapentin 300 mg PO at 8 PM for sleep

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Andrea Tsai, MD · Tufts Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-08-04
Completion
2025-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631510 on ClinicalTrials.gov