Sleep Disorders After TIPS

Sleep Disorder Clinical Trial

Official title:

The Incidence of Sleep Disorders After Transjugular Intrahepatic Portosystemic Shunt

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03685994
• Other study ID #: SD-TIPS
• Status: Recruiting
• Start date: August 31, 2018
• Est. completion date: August 2020

Study information

• Verified date: April 2019
• Source: West China Hospital
• Contact: Xufeng Luo, MD
• Phone: +86 13880098212
• Email: luo_xuefeng[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Purpose of a study to investigate the incidence of postoperative sleep disorders in patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the relationship between risk factors and prognosis of sleep disorders.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. History of cirrhosis (clinical or by liver biopsy)

2. Portal hypertension patients with defined indications for TIPS treatment

3. Aged 18-75 years old

4. Signed written informed consent

Exclusion Criteria:

1. mental or nervous system diseases

2. Patients with alcoholic cirrhosis who are still drinking

3. Accompanied by serious heart, lung, brain and kidney diseases

4. Preoperative diagnosis of sleep disorder

5. Patients who are illiteracy

6. The total score of the preoperative Hamilton anxiety scale was greater than or equal to 14 points, and the total score of 17 points of the Hamilton depression scale was greater than or equal to 18 points

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of sleep disorders after TIPS	The number of patients who suffer from sleep disorders after TIPS	1 year
Secondary	Incidence of hepatic encephalopathy	The number of patients who suffer from hepatic encephalopathy	1 year
Secondary	mortality	The number of patients who died	1 year