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Gabapentin 300 mg PO at 8 PM for Intensive Care Unit Sleep Disruption

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Intensive Care Unit Sleep DisruptionGabapentin 300 mg PO at 8 PM - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial will investigate whether the drug gabapentin can help improve sleep for people in the ICU.

Eligible Conditions
  • Intensive Care Unit Sleep Disruption

Treatment Effectiveness

Effectiveness Progress

1 of 3

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ALTO-300 PO tablet
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300 mg Gabapentin 3X per day
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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: for 12 hours after gabapentin administration

Hour 12
change in sleep efficiency
change in sleep quality
change in sleep quality: REM latency
change in sleep quality: sleep latency
change in sleep quality: total sleep duration/time (TST)
sleep quality: number of awakenings/arousals (#arousals/hour)

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
ALTO-300 PO tablet
3
300 mg Gabapentin 3X per day
3
Gabapentin

Trial Design

1 Treatment Group

Critically ill patients
1 of 1

Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: Gabapentin 300 mg PO at 8 PM · No Placebo Group · Phase < 1

Critically ill patients
Drug
Experimental Group · 1 Intervention: Gabapentin 300 mg PO at 8 PM · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: for 12 hours after gabapentin administration

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
238 Previous Clinical Trials
244,903 Total Patients Enrolled
Andrea Tsai, MDPrincipal InvestigatorTufts Medical Center

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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References

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