Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 1:08 AM
Study NCT ID:
NCT04818450
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'IGF-1', 'timeFrame': 'At day 0, 1, 3, and 5 after randomization', 'description': 'IGF-1 level'}], 'primaryOutcomes': [{'measure': 'Slow-wave sleep', 'timeFrame': 'at least 3 consecutive days after randomization', 'description': 'Slow-wave sleep period or deep sleep period'}], 'secondaryOutcomes': [{'measure': 'All-cause hospital mortality', 'timeFrame': 'During hospital stay or death or a maximum of 90 days', 'description': 'Rates of all-cause mortality during hospital stay'}, {'measure': 'ICU free days', 'timeFrame': 'During ICU stay or death or a maximum of 28 days', 'description': 'Days alive and not stay in ICU'}, {'measure': 'Mechanical ventilator free days', 'timeFrame': 'During ICU stay or death or a maximum of 28 days', 'description': 'Day alive and free of mechanical ventilator'}, {'measure': 'Hospital free days', 'timeFrame': 'During hospital stay or death or a maximum of 90 days', 'description': 'Days alive and not stay in hospital'}, {'measure': 'Incidence of self-extubation', 'timeFrame': 'During ICU stay or death or a maximum of 28 days', 'description': 'Number of patients who had self-extubation during ICU stay'}, {'measure': 'Incidence of sleep deprivation', 'timeFrame': 'During ICU stay or death or a maximum of 28 days', 'description': 'Times per patient-days of sleep deprivation during ICU stay'}, {'measure': 'Delirium free day', 'timeFrame': 'During ICU stay or death or a maximum of 28 days', 'description': 'Days alive and not having delirium'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gabapentin', 'sleep deprivation', 'critically ill patients', 'slow-wave sleep'], 'conditions': ['Sleep Deprivation', 'Critically Ill']}, 'referencesModule': {'references': [{'pmid': '30113379', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32148342', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29605589', 'type': 'RESULT', 'citation': "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."}, {'pmid': '12460250', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28769860', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '25317090', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '20124884', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '38803031', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years and older)\n* Patients admitted to ICU not more than 24 hours at the time of randomization\n\nExclusion Criteria:\n\n* Patients admitted to ICU less than 72 hours\n* Patients receiving gabapentin within 14 days prior to randomization\n* Patients receiving restorative drug (trazodone, mirtazapine, olanzapine, agomelatine, and pregabalin) within 7 days prior to randomization\n* Patients having contraindications to gabapentin\n* Patients receiving high dose vasopressors more than 1 hour during ICU admissions\n* Patients presenting with severe respiratory failure (PF ratio \\< 100)\n* Patients presenting with RASS \\< -2 at the time of randomization\n* Patients having target RASS of \\<-2 during ICU admissions\n* Terminal ill patients\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04818450', 'acronym': 'GASWAC', 'briefTitle': 'Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.', 'orgStudyIdInfo': {'id': 'MURA2021/170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin', 'description': 'Start 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.', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Not receiving gabapentin.'}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Gabapentin group'], 'description': 'Gabapentin 100-300 mg is given to the intervention group', 'armGroupLabels': ['Gabapentin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Ramathibodi Hospital, Mahidol University', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'overallOfficials': [{'name': 'Yuda Sutherasan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ramathibodi hospital, Mahidol university'}, {'name': 'Kanyarat Susantitapong, B.Sc.(Pharm)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}, {'name': 'Pitchaya Dilokpattanamongkol, BCPS, BCCCP, BCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mahidol University'}, {'name': 'Chuthamanee Suthisisang, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mahidol University'}, {'name': 'Viratch Tangsujaritvijit, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Piyavate Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}