Intensive Care Unit Sleep DisruptionEarly Phase 1NCT04631510
Gabapentin for Sleep in Critically Ill Patients
A Early Phase 1 study testing Gabapentin 300 mg PO at 8 PM in people with Intensive Care Unit Sleep Disruption, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Sleep Disruption
- What is being tested?
- Gabapentin 300 mg PO at 8 PM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 May 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the ICU or step-down unit (neurologic intermediate care center or Pratt 8) for ≥ 24 hours
- ≥ 1 risk factor for delirium: benzodiazepine use, blood transfusions, age >60 years, dementia, prior coma, pre-ICU emergency surgery or trauma, American Society of Anesthesia (ASA) score > 3, Acute Physiology and Chronic Health Evaluation II (APACHE II) >12, admission because of a neurologic disease, trauma, and the use of psychoactive medication (e.g., antipsychotics, anticonvulsants)
- Age ≥ 18 years old
- Anticipated ICU or step-down unit length of stay ≥ 48 hours past time of enrollment
- Riker score goal of 3 or 4
Who cannot join
- Pregnant women
- Age < 18 years old
- Wards of the state or prisoners
- Patients who were considered by their primary physician to be too unstable to undergo this investigation
- Comatose patients or patients with severe debilitating neurologic disease such as cerebrovascular accidents, intracranial hemorrhage, subdural hematoma, intracranial primary or secondary cancers, or anoxic-hypoxic encephalopathy
- Moribund patient expected to die within 24 hours
Show all 12Show fewer
- Expected change in intubation status within 24 hours of enrollment
- Gabapentin or pregabalin use in the last 7 days or at baseline
- Patients with a known sensitivity to gabapentin
- Currently receiving a non-benzodiazepine hypnotic (i.e. zolpidem, eszopiclone)
- Need for every hour neurologic checks
- Creatinine clearance < 15ml/min or need for renal replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of 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 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.
Read the detailed description
Sleep disruption in the intensive care unit (ICU) is a common comorbidity. In addition to being a source of emotional distress for many patients, sleep disturbance may be associated with ICU delirium, prolonged need for respiratory support, and immune and neurocognitive dysfunction. Since sleep is a potentially modifiable risk factor for ICU outcomes, there has been increased interest in sleep study and promotion in critically ill patients, as evidenced by the inclusion of sleep disruption in the 2018 Society of Critical Care Medicine Clinical Practice Guidelines. Although these Guidelines make soft recommendations for non-pharmacologic strategies to improve sleep in this patient population, these strategies are often lacking in efficacy and/or evidence. 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. In non-ICU patients, gabapentin is an effective therapy for insomnia in patients with restless leg syndrome or chronic neuropathy. Even in patients without these comorbidities, gabapentin has shown efficacy compared with placebo in improving sleep duration and depth. Gabapentin has several advantages compared to common sedatives used in the ICU, including no increased day drowsiness, no QTc prolongation, and some studies suggesting no association with delirium, particularly when used in a daily dose < 600 mg. Although caution must be used in dosing this drug in patients with renal dysfunction, a dose of up to 300 mg daily may be used if CrCl < 15 ml/m, and doses of up to 300 mg after hemodialysis (HD) have been used safely in patients with end stage renal disease (ESRD). Additionally, its generic status and broad therapeutic index make it a cost-effective and attractive agent for further study and use.
Here investigators propose a pilot study of gabapentin as a therapy for sleep disruption in the ICU. To date, there have been no studies of gabapentin use for sleep in the ICU; this study would represent the first of its kind. Given the magnitude of the problem represented by sleep disruption in the ICU, the ability of gabapentin to mitigate insomnia in outpatients, and the low side effect profile and wide therapeutic window of gabapentin, studying the effects of gabapentin on sleep disruption in the ICU is a logical and potentially practice changing step.
- Conditions
- Intensive Care Unit Sleep Disruption
- Being tested
- Gabapentin 300 mg PO at 8 PM
- Keywords
- Sleep disruption, intensive care unit, gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 300 mg PO at 8 PMDrug
Administer gabapentin 300 mg PO at 8 PM for sleep
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Experimental | Administer gabapentin 300 mg PO at 8 PM for sleep Receives: Drug: Gabapentin 300 mg PO at 8 PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in sleep efficiency
improvement in sleep efficiency index (SEI) over baseline as measured by Richards-Campbell Sleep Questionnaire (RCSQ)
Measured: for 12 hours after gabapentin administration
Secondary outcomes (5)
change in sleep quality: total sleep duration/time (TST)
BIS monitoring for total sleep duration/time (TST)
Measured: for 12 hours after gabapentin administration
change in sleep quality: sleep latency
Sleep efficiency (TST/TRT), sleep latency
Measured: for 12 hours after gabapentin administration
change in sleep quality: REM latency
REM latency
Measured: for 12 hours after gabapentin administration
change in sleep quality
wakefulness after sleep onset (WASO)
Measured: for 12 hours after gabapentin administration
sleep quality: number of awakenings/arousals (#arousals/hour)
number of awakenings/arousals (#arousals/hour)
Measured: for 12 hours after gabapentin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Dec 2020
- Primary completion4 Aug 2023
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Sleep DisruptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Tsai, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631510
- Sponsor's protocol ID
- 13560
- Status last verified
- Jun 2025
- First submitted
- 3 Dec 2019
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Gabapentin for Sleep in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04631510
- Acronym / sponsor ID
- 13560
- Conditions
- Intensive Care Unit Sleep Disruption
- Keywords
- Sleep disruption, intensive care unit, gabapentin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sleep disruption in the intensive care unit (ICU) is a common comorbidity. In addition to being a source of emotional distress for many patients, sleep disturbance may be associated with ICU delirium, prolonged need for respiratory support, and immune and neurocognitive dysfunction. Since sleep is a potentially modifiable risk factor for ICU outcomes, there has been increased interest in sleep study and promotion in critically ill patients, as evidenced by the inclusion of sleep disruption in the 2018 Society of Critical Care Medicine Clinical Practice Guidelines. Although these Guidelines make soft recommendations for non-pharmacologic strategies to improve sleep in this patient population, these strategies are often lacking in efficacy and/or evidence. 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. In non-ICU patients, gabapentin is an effective therapy for insomnia in patients with restless leg syndrome or chronic neuropathy. Even in patients without these comorbidities, gabapentin has shown efficacy compared with placebo in improving sleep duration and depth. Gabapentin has several advantages compared to common sedatives used in the ICU, including no increased day drowsiness, no QTc prolongation, and some studies suggesting no association with delirium, particularly when used in a daily dose < 600 mg. Although caution must be used in dosing this drug in patients with renal dysfunction, a dose of up to 300 mg daily may be used if CrCl < 15 ml/m, and doses of up to 300 mg after hemodialysis (HD) have been used safely in patients with end stage renal disease (ESRD). Additionally, its generic status and broad therapeutic index make it a cost-effective and attractive agent for further study and use.
Here investigators propose a pilot study of gabapentin as a therapy for sleep disruption in the ICU. To date, there have been no studies of gabapentin use for sleep in the ICU; this study would represent the first of its kind. Given the magnitude of the problem represented by sleep disruption in the ICU, the ability of gabapentin to mitigate insomnia in outpatients, and the low side effect profile and wide therapeutic window of gabapentin, studying the effects of gabapentin on sleep disruption in the ICU is a logical and potentially practice changing step.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | Experimental | Drug: Gabapentin 300 mg PO at 8 PMAdminister gabapentin 300 mg PO at 8 PM for sleep |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to the ICU or step-down unit (neurologic intermediate care center or Pratt 8) for ≥ 24 hours
- ≥ 1 risk factor for delirium: benzodiazepine use, blood transfusions, age >60 years, dementia, prior coma, pre-ICU emergency surgery or trauma, American Society of Anesthesia (ASA) score > 3, Acute Physiology and Chronic Health Evaluation II (APACHE II) >12, admission because of a neurologic disease, trauma, and the use of psychoactive medication (e.g., antipsychotics, anticonvulsants)
- Age ≥ 18 years old
- Anticipated ICU or step-down unit length of stay ≥ 48 hours past time of enrollment
- Riker score goal of 3 or 4
Key exclusion criteria (12 listed)
- Pregnant women
- Age < 18 years old
- Wards of the state or prisoners
- Patients who were considered by their primary physician to be too unstable to undergo this investigation
- Comatose patients or patients with severe debilitating neurologic disease such as cerebrovascular accidents, intracranial hemorrhage, subdural hematoma, intracranial primary or secondary cancers, or anoxic-hypoxic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin 300 mg PO at 8 PMAdminister gabapentin 300 mg PO at 8 PM for sleep | Drug | Critically ill patients |
Primary outcome
change in sleep efficiency
Time frame: for 12 hours after gabapentin administration
improvement in sleep efficiency index (SEI) over baseline as measured by Richards-Campbell Sleep Questionnaire (RCSQ)
5 secondary outcomes
change in sleep quality: total sleep duration/time (TST)
Time frame: for 12 hours after gabapentin administration
change in sleep quality: sleep latency
Time frame: for 12 hours after gabapentin administration
change in sleep quality: REM latency
Time frame: for 12 hours after gabapentin administration
change in sleep quality
Time frame: for 12 hours after gabapentin administration
sleep quality: number of awakenings/arousals (#arousals/hour)
Time frame: for 12 hours after gabapentin administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Tsai, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gabapentin 300 mg PO at 8 PM in people with Intensive Care Unit Sleep Disruption, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in sleep efficiency (time frame: for 12 hours after gabapentin administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.