Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-04-02 @ 10:35 AM
Study NCT ID:
NCT04771104
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2021-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-14', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the late post-illumination pupillary response after intervention compared to placebo', 'timeFrame': '12 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Encephalopathy', 'Liver Cirrhosis', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'pmid': '36170326', 'type': 'DERIVED', 'citation': 'Kann AE, Ba-Ali S, Seidelin JB, Larsen FS, Hamann S, Bjerring PN. The effect of induced hyperammonaemia on sleep and melanopsin-mediated pupillary light response in patients with liver cirrhosis: A single-blinded randomized crossover trial. PLoS One. 2022 Sep 28;17(9):e0275067. doi: 10.1371/journal.pone.0275067. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Sleep disturbances are common among patients with liver cirrhosis, but the reasons are not well understood. In this project the investigators evaluated whether an increase in blood ammonia in patients with cirrhosis had an impact on sleep quality and the function of retinal ganglion cells measured by pupillary response to blue light.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis\n* Written informed consent\n* \\>20 and \\<80 years of age\n\nExclusion Criteria:\n\n* Misuse of alcohol in the preceding 6 months,\n* Episodes of hepatic decompensation leading to in-patient admissions during the previous month\n* History or clinical signs of overt HE or severe sleep-wake disturbances\n* On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino)\n* History of significant head injury\n* Neurological/psychiatric comorbidity needing medical treatment\n* Taking neuroactive medication/medication known to affect sleep\n* Travel across more than two time zones in the preceding 3 months\n* Shift work in the preceding 5 years\n* Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).'}, 'identificationModule': {'nctId': 'NCT04771104', 'briefTitle': 'The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'orgStudyIdInfo': {'id': 'H15000210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Allocated to intervention at first experimental day', 'interventionNames': ['Dietary Supplement: Amino Acid Challenge (AAC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Allocated to intervention at second experimental day', 'interventionNames': ['Dietary Supplement: Amino Acid Challenge (AAC)']}], 'interventions': [{'name': 'Amino Acid Challenge (AAC)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The AAC contains 54 g banana flavoured amino acid mixture added 200-300 mL of water. The AAC simulates the composition of haemoglobin in approximately 400 mL of blood.', 'armGroupLabels': ['Allocated to intervention at first experimental day', 'Allocated to intervention at second experimental day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of gastroenterology and hepatology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant hepatologist, associate professor', 'investigatorFullName': 'Peter Nissen Bjerring', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}