Liver CirrhosisNCT02710227
Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
An observational study of Liver Cirrhosis, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- (PSQI), (STQ).
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2018to Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited.
Who may be able to join
- Liver cirrhosis
- controls
Who cannot join
- HCC
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta university - faculty of medicine
Tanta, Elgharbia
Sherief Abdelsalam, lecturer, 00201095159522, Sheriefabdelsalam@yahoo.com
About this study
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
Read the detailed description
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
- Conditions
- Liver Cirrhosis
- Being tested
- (PSQI), (STQ).
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(PSQI), (STQ).Other
Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
| Study group | Role | What they receive |
|---|---|---|
| liver cirrhosis | Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ). Receives: Other: (PSQI), (STQ). | |
| control | Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ). Receives: Other: (PSQI), (STQ). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals with sleep disturbances
Number of individuals with sleep disturbances among cirrhotics
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 posted16 Mar 2016 (estimated)
- Study startSep 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Mohamed yousef, MD, Principal investigator, Hepatology and gastroenterology dept.-TantaMohamed seleem, MD, Study director, Neuropsychiatry dept.- TantaSherief Abd-Elsalam, MD, Study director, Hepatology and gastroenterology dept.-TantaMohamed Elhendawy, MD, Study chair, Hepatology and gastroenterology dept.-TantaSabry Abou saif, MD, Study chair, Hepatology and gastroenterology dept.-TantaAbdelrahman Kobtan, MD, Study chair, Hepatology and gastroenterology dept.-Tanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710227
- Sponsor's protocol ID
- Sleep Patterns in cirrhotics
- Status last verified
- Jun 2017
- First submitted
- 9 Mar 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
- ClinicalTrials.gov ID
- NCT02710227
- Acronym / sponsor ID
- Sleep Patterns in cirrhotics
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Mar 2016 (estimated)
- 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.
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
Detailed description
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver cirrhosis | – | Other: (PSQI), (STQ).Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ). |
| control | – | Other: (PSQI), (STQ).Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited.
Key inclusion criteria (2 listed)
- Liver cirrhosis
- controls
Key exclusion criteria (1 listed)
- HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (PSQI), (STQ).Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ). | Other | control, liver cirrhosis |
Primary outcome
Number of individuals with sleep disturbances
Time frame: 1 year
Number of individuals with sleep disturbances among cirrhotics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Mohamed yousef, MD principal investigator
Hepatology and gastroenterology dept.-Tanta
Mohamed seleem, MD study director
Neuropsychiatry dept.- Tanta
Sherief Abd-Elsalam, MD study director
Hepatology and gastroenterology dept.-Tanta
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 Liver Cirrhosis, run by Sherief Abd-Elsalam at 1 site in Egypt.
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 2 inclusion and 1 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 20 Jun 2017. 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 Egypt. 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 Sherief Abd-Elsalam, MD (00201095159522, sherif_tropical@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals with sleep disturbances (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2017.