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

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.

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Failure Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of gastroenterology and hepatology, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Amino Acid Challenge (AAC)

Dietary Supplement

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.

Primary outcomes

Difference in the late post-illumination pupillary response after intervention compared to placebo

Time frame: 12 days

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Feb 25, 2021
Registry last updated: Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed