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NCT04631510 · ClinicalTrials.gov registry record · Early Phase 1
Gabapentin for Sleep in Critically Ill Patients
A Early Phase 1 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 80
- Enrollment target
NCT04631510: Completed Early Phase 1 study, sponsored by Tufts Medical Center.
NCT04631510 is a Early Phase 1 study that has completed, run by Tufts Medical Center. The registered enrollment target is 80 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04631510, a Early Phase 1 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 80 participants
- Enrollment target
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.
Primary Outcome
improvement in sleep efficiency index (SEI) over baseline as measured by Richards-Campbell Sleep Questionnaire (RCSQ)
Interventions
- DRUG Gabapentin 300 mg PO at 8 PM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2025-05-30 |
| Phase | Early Phase 1 |
What the finished NCT04631510 record still lists
NCT04631510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% higher).
The record links to 0 conditions, and to 1 intervention - of which Gabapentin 300 mg PO at 8 PM is the first listed.
NCT04631510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04631510 about?
NCT04631510 is a clinical study titled "Gabapentin for Sleep in Critically Ill Patients". 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 b...
What is the current status of trial NCT04631510?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2020-12-01. Estimated completion is 2025-05-30.
What interventions are being tested in trial NCT04631510?
The interventions under investigation include: Gabapentin 300 mg PO at 8 PM (DRUG).
Who is sponsoring clinical trial NCT04631510?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04631510's enrollment target sits among peer trials
80 271st of 2000 higher than 1,704 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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