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Sleep DeprivationGASWACNCT04818450

Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient

A study testing Gabapentin in people with Sleep Deprivation and Critically Ill, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Deprivation, Critically Ill
What is being tested?
Gabapentin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteThailand
Study dates
19 Apr 2021to 31 Jul 2022
Phase
Interventional
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

  • Adults (18 years and older)
  • Patients admitted to ICU not more than 24 hours at the time of randomization

Who cannot join

  • Patients admitted to ICU less than 72 hours
  • Patients receiving gabapentin within 14 days prior to randomization
  • Patients receiving restorative drug (trazodone, mirtazapine, olanzapine, agomelatine, and pregabalin) within 7 days prior to randomization
  • Patients having contraindications to gabapentin
  • Patients receiving high dose vasopressors more than 1 hour during ICU admissions
  • Patients presenting with severe respiratory failure (PF ratio < 100)
Show all 10Show fewer
  • Patients presenting with RASS < -2 at the time of randomization
  • Patients having target RASS of <-2 during ICU admissions
  • Terminal ill patients
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Ramathibodi Hospital, Mahidol University

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

About this study

Official title: Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.

The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

Read the detailed description

Up to 61% of critically ill patients have sleep deprivation in ICU. Sleep deprivation can cause delirium and lead to prolonged ICU length of stay and mechanical ventilator days. However, pharmacologic interventions to improve sleep quality and prevent sleep deprivation are poorly tested for efficacy and safety in ICU patients. There were reports of gabapentin increasing slow-wave sleep in healthy populations and insomnia patients with insignificant adverse events. Therefore, gabapentin might increase slow-wave sleep resulting in improving clinical outcomes in adult critically ill patients. The objectives of the study were to evaluate the efficacy, especially on slow-wave sleep, and safety of gabapentin in adult critically ill patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand.

Being tested
Gabapentin
Keywords
gabapentin, sleep deprivation, critically ill patients, slow-wave sleep
Medical subject headings
Sleep Deprivation, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GabapentinDrug

    Also called Gabapentin group

    Gabapentin 100-300 mg is given to the intervention group

Study groups in NCT04818450
Study groupRoleWhat they receive
GabapentinExperimentalStart gabapentin 100 mg at 9.00 PM on the second night of ICU admission and titrate gabapentin dose as needed. Maximum gabapentin dose in this study is 300 mg/day.
Receives: Drug: Gabapentin
Standard careNo interventionNot receiving gabapentin.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Slow-wave sleep

    Slow-wave sleep period or deep sleep period

    Measured: at least 3 consecutive days after randomization

Secondary outcomes (7)

  1. All-cause hospital mortality

    Rates of all-cause mortality during hospital stay

    Measured: During hospital stay or death or a maximum of 90 days

  2. ICU free days

    Days alive and not stay in ICU

    Measured: During ICU stay or death or a maximum of 28 days

  3. Mechanical ventilator free days

    Day alive and free of mechanical ventilator

    Measured: During ICU stay or death or a maximum of 28 days

  4. Hospital free days

    Days alive and not stay in hospital

    Measured: During hospital stay or death or a maximum of 90 days

  5. Incidence of self-extubation

    Number of patients who had self-extubation during ICU stay

    Measured: During ICU stay or death or a maximum of 28 days

  6. Incidence of sleep deprivation

    Times per patient-days of sleep deprivation during ICU stay

    Measured: During ICU stay or death or a maximum of 28 days

  7. Delirium free day

    Days alive and not having delirium

    Measured: During ICU stay or death or a maximum of 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start19 Apr 2021
  3. Primary completion25 Jun 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04818450
Sponsor's protocol ID
MURA2021/170
Acronym
GASWAC
Status last verified
Aug 2022
First submitted
25 Mar 2021
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

    PubMed 30113379

  • Arttawejkul P, Reutrakul S, Muntham D, Chirakalwasan N. Effect of Nighttime Earplugs and Eye Masks on Sleep Quality in Intensive Care Unit Patients. Indian J Crit Care Med. 2020 Jan;24(1):6-10. doi: 10.5005/jp-journals-10071-23321.

    PubMed 32148342

  • Carrera-Hernandez L, Aizpitarte-Pejenaute E, Zugazagoitia-Ciarrusta N, Goni-Viguria R. Patients' perceptions of sleep in a Critical Care Unit. Enferm Intensiva (Engl Ed). 2018 Apr-Jun;29(2):53-63. doi: 10.1016/j.enfi.2018.01.002. Epub 2018 Mar 28. English, Spanish.

    PubMed 29605589

  • Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia. 2002 Dec;43(12):1493-7. doi: 10.1046/j.1528-1157.2002.21002.x.

    PubMed 12460250

  • Liu GJ, Karim MR, Xu LL, Wang SL, Yang C, Ding L, Wang YF. Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis. Front Neurol. 2017 Jul 14;8:316. doi: 10.3389/fneur.2017.00316. eCollection 2017.

    PubMed 28769860

  • Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.

    PubMed 25317090

  • Lo HS, Yang CM, Lo HG, Lee CY, Ting H, Tzang BS. Treatment effects of gabapentin for primary insomnia. Clin Neuropharmacol. 2010 Mar-Apr;33(2):84-90. doi: 10.1097/WNF.0b013e3181cda242.

    PubMed 20124884

  • Susantitapong K, Dilokpattanamongkol P, Sutherasan Y, Liamsombut S, Suthisisang C. Effects of gabapentin on slow-wave sleep period in critically ill adult patients: A randomized controlled trial. Clin Transl Sci. 2024 May;17(5):e13815. doi: 10.1111/cts.13815.

    PubMed 38803031

Questions about this trial

What is this clinical trial studying?

A study testing Gabapentin in people with Sleep Deprivation and Critically Ill, run by Mahidol University at 1 site in Thailand.

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 2 inclusion and 10 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 11 Aug 2022. 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 Thailand. 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.

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?

Slow-wave sleep (time frame: at least 3 consecutive days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04818450, which also lists 8 linked publications.

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 11 Aug 2022.

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