The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis

Not Applicable

Completed

• Conditions: Hepatic Encephalopathy; Liver Cirrhosis; Sleep Disturbance
• Interventions: Dietary Supplement: Amino Acid Challenge (AAC)

• Registration Number: NCT04771104
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-01-09
• Study Completion: 2018-01-22
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-14
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
• Written informed consent
• >20 and <80 years of age

Exclusion Criteria

• Misuse of alcohol in the preceding 6 months,
• Episodes of hepatic decompensation leading to in-patient admissions during the previous month
• History or clinical signs of overt HE or severe sleep-wake disturbances
• On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino)
• History of significant head injury
• Neurological/psychiatric comorbidity needing medical treatment
• Taking neuroactive medication/medication known to affect sleep
• Travel across more than two time zones in the preceding 3 months
• Shift work in the preceding 5 years
• Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Allocated to intervention at first experimental day	Amino Acid Challenge (AAC)	-
Allocated to intervention at second experimental day	Amino Acid Challenge (AAC)	-

Primary Outcome Measures

Name	Time	Method
Difference in the late post-illumination pupillary response after intervention compared to placebo	12 days

Trial Locations

Locations (1)

Department of gastroenterology and hepatology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark