Sleep DisorderNCT03685994
Sleep Disorders After TIPS
An observational study of Sleep Disorder, run by West China Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Disorder
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2018to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients who underwent TIPS in our hospital due to cirrhosis and portal hypertension.
Who may be able to join
- History of cirrhosis (clinical or by liver biopsy)
- Portal hypertension patients with defined indications for TIPS treatment
- Aged 18-75 years old
- Signed written informed consent
Who cannot join
- mental or nervous system diseases
- Patients with alcoholic cirrhosis who are still drinking
- Accompanied by serious heart, lung, brain and kidney diseases
- Preoperative diagnosis of sleep disorder
- Patients who are illiteracy
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Xuefeng Luo, MD, 862885422389
About this study
Official title: The Incidence of Sleep Disorders After Transjugular Intrahepatic Portosystemic Shunt
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.
- Conditions
- Sleep Disorder
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the patients who will undergo TIPS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of sleep disorders after TIPS
The number of patients who suffer from sleep disorders after TIPS
Measured: 1 year
Secondary outcomes (2)
Incidence of hepatic encephalopathy
The number of patients who suffer from hepatic encephalopathy
Measured: 1 year
mortality
The number of patients who died
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start31 Aug 2018
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luo xuefeng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685994
- Sponsor's protocol ID
- SD-TIPS
- Status last verified
- Apr 2019
- First submitted
- 23 Sep 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao M, Yan Y, Wang X, Liu B, Luo X. Sleep disturbance in patients with cirrhosis and transjugular intrahepatic portosystemic shunt. BMC Gastroenterol. 2024 Oct 28;24(1):381. doi: 10.1186/s12876-024-03470-x.
PubMed 39465397
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Sleep Disorders After Transjugular Intrahepatic Portosystemic Shunt
- ClinicalTrials.gov ID
- NCT03685994
- Acronym / sponsor ID
- SD-TIPS
- Conditions
- Sleep Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the patients who will undergo TIPS | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients who underwent TIPS in our hospital due to cirrhosis and portal hypertension.
Key inclusion criteria (4 listed)
- History of cirrhosis (clinical or by liver biopsy)
- Portal hypertension patients with defined indications for TIPS treatment
- Aged 18-75 years old
- Signed written informed consent
Key exclusion criteria (6 listed)
- mental or nervous system diseases
- Patients with alcoholic cirrhosis who are still drinking
- Accompanied by serious heart, lung, brain and kidney diseases
- Preoperative diagnosis of sleep disorder
- Patients who are illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of sleep disorders after TIPS
Time frame: 1 year
The number of patients who suffer from sleep disorders after TIPS
2 secondary outcomes
Incidence of hepatic encephalopathy
Time frame: 1 year
mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Derived from this study: PubMed 39465397Zhao M, Yan Y, Wang X, Liu B, Luo X. Sleep disturbance in patients with cirrhosis and transjugular intrahepatic portosystemic shunt. BMC Gastroenterol. 2024 Oct 28;24(1):381. doi: 10.1186/s12876-024-03470-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xufeng Luo, MD (+86 13880098212, luo_xuefeng@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of sleep disorders after TIPS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.