- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02710227
Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
Studieoversigt
Detaljeret beskrivelse
Cirrhosis of the liver is a chronic, diffuse, degenerative disease in which the parenchyma deteriorates, the lobules are infiltrated with fat and structurally altered, dense perilobular connective tissue forms and often areas of regeneration develop. These regeneration nodules have a reduced blood supply resulting in impaired liver function [1] and [2]. Factors that are taken into account to determine the severity of cirrhosis include serum albumin, prothrombin concentration, serum bilirubin, ascites and encephalopathy. A point system known as the Child's-pough-Turcotte score has been designed to determine the severity of cirrhosis. Depending on the total score, patients are classified as class A (early cirrhosis) through class C (advanced cirrhosis) [3].
A disturbance of sleep is recognized as one of the early signs of hepatic encephalopathy. Reversal of sleep rhythm, drowziness and lethargy are classic signs of this disease. Sleep disturbance and excessive daytime somnolence are common in patients with cirrhosis. It was estimated that up to 70% of individuals with cirrhosis (regardless of etiology) experience sleep disturbances [4]. Difficulty falling asleep and a shift in sleep schedule toward the latter part of the night, which might be result in daytime sleepiness, are commonly reported findings in patients with hepatic cirrhosis without encephalopathy [4].
Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited. Sleep quality, sleep timing parameters and circadian preference were evaluated using the Pittsburgh Sleep Quality Index (PSQI), Sleep Timing Questionnaire (STQ) and The Composite Scale for Morningness (CSM) respectively
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Elgharbia
-
Tanta, Elgharbia, Egypten
- Tanta university - faculty of medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Liver cirrhosis
- controls
Exclusion Criteria:
- HCC
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
liver cirrhosis
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
|
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
|
|
control
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
|
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of individuals with sleep disturbances
Tidsramme: 1 year
|
Number of individuals with sleep disturbances among cirrhotics
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mohamed yousef, MD, Hepatology and gastroenterology dept.-Tanta
- Studieleder: Mohamed seleem, MD, Neuropsychiatry dept.- Tanta
- Studieleder: Sherief Abd-Elsalam, MD, Hepatology and gastroenterology dept.-Tanta
- Studiestol: Mohamed Elhendawy, MD, Hepatology and gastroenterology dept.-Tanta
- Studiestol: Sabry Abou saif, MD, Hepatology and gastroenterology dept.-Tanta
- Studiestol: Abdelrahman Kobtan, MD, Hepatology and gastroenterology dept.-Tanta
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Sleep Patterns in cirrhotics
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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