Gabapentin for Sleep Disruption in Critical Illness

Overseen By Iwona Bonney, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Tufts Medical Center

Must not be taking: Gabapentin, Pregabalin, Non-benzodiazepine hypnotics

Disqualifiers: Pregnancy, Severe neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 night

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you have used gabapentin or pregabalin in the last 7 days or are currently taking certain sleep medications like zolpidem or eszopiclone.

What data supports the effectiveness of the drug gabapentin for sleep disruption in critical illness?

Research shows that gabapentin can improve sleep in people with medical illnesses and those experiencing sleep disruption due to alcohol consumption, suggesting it may help with sleep issues in critical illness as well. ^{1 2 3 4 5}

Is Gabapentin safe for use in humans?

Gabapentin, also known as Neurontin, has been used for various conditions and is generally considered safe for humans, but like any medication, it can have side effects. It's important to discuss with your doctor to understand the risks and benefits specific to your situation. ^{6 7 8 9 10}

How does the drug gabapentin differ from other treatments for sleep disruption in critical illness?

Gabapentin is unique because it is primarily an antiepileptic drug that also helps improve sleep by reducing brain hyperactivity, which can be beneficial for patients experiencing sleep disturbances due to critical illness. Unlike other treatments, gabapentin has been shown to alleviate sleep problems associated with neuropathic pain and alcohol consumption, suggesting its potential versatility in managing sleep issues. ^{1 3 4 11 12}

What is the purpose of this trial?

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.

Research Team

Andrea Tsai, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I expect to stay in intensive care or a similar unit for at least 48 hours after joining.

I am over 60 or have other risk factors for confusion after surgery.

My goal is to be calm but awake.

Exclusion Criteria

Pregnant women

You are very sick and expected to pass away in the next day.

You are allergic or have had a bad reaction to gabapentin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Measurement

Baseline sleep measurements are taken on the first night

1 night

In-person monitoring

Treatment

Participants receive gabapentin 300 mg for sleep, with sleep measurements repeated

1 night

In-person monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 hours

Treatment Details

Interventions

• Gabapentin

Trial Overview 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.

Participant Groups

Group I: Critically ill patients Experimental Treatment 1 Intervention

Administer gabapentin 300 mg PO at 8 PM for sleep

Gabapentin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurontin for:

• Postherpetic neuralgia
• Partial-onset seizures

Approved in European Union as Gabapentin for:

• Peripheral neuropathic pain
• Partial-onset seizures

Approved in Canada as Gabapentin for:

• Postherpetic neuralgia
• Partial-onset seizures

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Findings from Research

Gabapentin is a new antiepileptic drug approved for use as an add-on treatment for patients with partial or secondarily generalized seizures that are not well controlled by standard antiepileptic medications.

Similar to lamotrigine, gabapentin offers an additional option for patients struggling to manage their seizures effectively with existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin--a new antiepileptic drug. [2018]

In a 20-week study involving 141 patients with partial seizures, gabapentin significantly reduced seizure frequency, with 71% of participants experiencing a 50% or greater decrease in seizures, and 46% becoming seizure-free in the last 8 weeks.

Gabapentin also improved quality of life, as shown by significant enhancements in 5 out of 10 questions on the QOLIE-10 questionnaire, indicating that it not only helps with seizure control but also positively affects patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome evaluation of gabapentin as add-on therapy for partial seizures. "NEON" Study Investigators Group. Neurontin Evaluation of Outcomes in Neurological Practice. Bruni, J.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis. [2023]

2. Brazil pubmed.ncbi.nlm.nih.gov

[Effect of melatonin on the daytime sleepiness side-effect of gabapentin in adults patients with neuropathic pain]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Gabapentin--a new antiepileptic drug. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Gabapentin improves sleep in the presence of alcohol. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Outcome evaluation of gabapentin as add-on therapy for partial seizures. "NEON" Study Investigators Group. Neurontin Evaluation of Outcomes in Neurological Practice. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Sleep disruption in critically ill patients--pharmacological considerations. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Sleep in the critically ill patient. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effect of ketamine administration on nocturnal sleep architecture. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep deprivation in critical illness: its role in physical and psychological recovery. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Sleep in the Intensive Care Unit: A Review. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Gabapentin-induced modulation of interictal epileptiform activity related to different vigilance levels. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Effects of gabapentin on brain hyperactivity related to pain and sleep disturbance under a neuropathic pain-like state using fMRI and brain wave analysis. [2018]