- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02710227
Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
Studieoversikt
Detaljert 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
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
Elgharbia
-
Tanta, Elgharbia, Egypt
- Tanta university - faculty of medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Liver cirrhosis
- controls
Exclusion Criteria:
- HCC
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of individuals with sleep disturbances
Tidsramme: 1 year
|
Number of individuals with sleep disturbances among cirrhotics
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: 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
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Sleep Patterns in cirrhotics
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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