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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether gabapentin can improve sleep for critically ill ICU patients who often struggle with sleep issues. Typically used for nerve pain, gabapentin might also aid sleep. The trial will compare patients' sleep quality with gabapentin to their usual sleep in the ICU. It seeks patients who have been in the ICU for at least 24 hours and have factors like recent surgery or trauma that could cause confusion or agitation. Participants should expect to remain in the ICU for at least two more days after joining the trial. As an Early Phase 1 trial, this research focuses on understanding how gabapentin works in people, offering participants a chance to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that gabapentin is likely to be safe for humans?

Research has shown that gabapentin, a drug commonly used for seizures and nerve pain, has been studied for its impact on sleep quality in very sick patients. Some studies found that gabapentin can increase deep sleep, a stage that helps the body rest and recover. This could benefit patients in intensive care.

Regarding safety, gabapentin is usually well-tolerated but can have side effects. The FDA has noted that gabapentin may cause serious breathing problems, especially in patients with existing breathing issues or those taking other medications that affect breathing. Participants should be aware of these risks and discuss them with the trial team.

Overall, while gabapentin shows promise for improving sleep, potential side effects should be considered carefully. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for sleep disruption in critically ill patients, which often include sedatives like benzodiazepines or antipsychotics, gabapentin offers a unique approach by targeting the body's pain pathways to promote better sleep. Gabapentin is originally used for nerve pain and seizures, but it has shown potential for improving sleep quality without the sedative side effects commonly associated with traditional sleep aids. Researchers are excited about gabapentin because it could provide a safer alternative that minimizes the risks of over-sedation and dependence, which are significant concerns with current medications.

What evidence suggests that gabapentin might be an effective treatment for sleep disruption in the ICU?

Research has shown that gabapentin, which participants in this trial will receive, can improve sleep for those experiencing sleep disturbances due to illness. Studies have found that gabapentin enhances deep sleep, the most restful part of the sleep cycle. Better deep sleep can reduce confusion and accelerate recovery in very sick patients. Previous research suggests that gabapentin effectively improves sleep quality in adults with sleep problems. Unlike some other treatments, it does not appear to cause more issues than it resolves. ^{1 2 4 6 7}

Who Is on the Research Team?

Andrea Tsai, MD

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11130453/

Effects of gabapentin on slow‐wave sleep period in critically ill ... Sleep deprivation is one of the most common problems in critically ill patients and is associated with delirium, slow recovery, and prolonged ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04818450

Impact of Gabapentin on Slow Wave Sleep in Adult ... Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis. Front Neurol. 2017 Jul ...

3. withpower.com withpower.com/trial/early-phase-1-critical-illness-11-2020-16f2a

Gabapentin for Sleep Disruption in Critical Illness ... patients experiencing sleep disturbances due to critical illness. Unlike other treatments, gabapentin has been shown to alleviate sleep problems associated ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5510619/

Efficacy and Tolerability of Gabapentin in Adults with Sleep ... We found that regardless the type of sleep outcomes, gabapentin displayed stable treatment efficacy for sleep disturbance in patients with medical illness.

5. ctv.veeva.com ctv.veeva.com/study/gabapentin-for-sleep-in-critically-ill-patients

Gabapentin for Sleep in Critically Ill Patients In addition to being a source of emotional distress for many patients, sleep disturbance may be associated with ICU delirium, prolonged need ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38803031/

Effects of gabapentin on slow-wave sleep period in ... Gabapentin at bedtime increased SWS, TST, and IGF-1 concentrations in critically ill patients. This regimen might be beneficial to critically ill patients for ...

7. fda.gov fda.gov/media/133681/download

FDA warns about serious breathing problems with seizure ... The U.S. Food and Drug Administration (FDA) is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, ...