Sleep DisorderNCT05536817
Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity
An observational study of Sleep Disorder and Inflammatory Bowel Diseases, run by Mahidol University at 1 site in Thailand.
Trial summary
Recently, an association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. This study aimed to investigate prevalence of poor sleep quality in IBD and association with disease activity by subjective and objective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder, Inflammatory Bowel Diseases
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 5 Feb 2021to Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients over 18 years of age diagnosed with inflammatory bowel disease, either UC or CD. In addition, patients with non-IBD-related conditions that potentially impacted sleep quality will be excluded
Who may be able to join
- Age ≥ 18 years
- Diagnosed inflammatory bowel disease, followed up in Siriraj hospital, Mahidol University
Who cannot join
- Unstable medical conditions
- Known psychiatric disease
- Patients who could not withhold sedative drugs
- Pregnant patients
- Obese patients with body mass index (BMI) ≥ 35 kg/m2
- Refuse to sign a consent/ had cognitive impairment
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
Julajak Limsrivilai, MD, +66814968895, alimsrivilai@gmail.com
Julajak Limsrivilai
About this study
Official title: Prevalence of Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity
Recently, an association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. This study aimed to investigate prevalence of poor sleep quality in IBD and association with disease activity by subjective and objective measures.
Prospective observational study is conducted with expected sample size of 100 patients. Participants are classified into active and inactive disease status according to standard IBD severity assessment measures. Demographic data, disease activity, quality of life, sleep questionnaire (validated PSQI questionaire), and seven-day sleep data acquired from ambulatory wrist actigraphy were obtained. Association between sleep quality and disease activity will be analyzed.
- Conditions
- Sleep Disorder, Inflammatory Bowel Diseases
- Medical subject headings
- Sleep Wake Disorders, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sleep quality
PSQI (Pittsburg sleep questionaire index) scores at first day then every month. PSQI contains ten questions, scoring provides sleep duration, latency, disturbance, efficiency, and quality. Total PSQI score of > 5 indicates poor sleep quality.
Measured: 12 months
Objective sleep quality
Sleep efficiency (percentage of total sleep time compared to time-in-bed) provided by ambulatory wrist actigraphy on first seven consecutive days and at 12-month period. Score less than 85% is considered poor sleep quality.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start5 Feb 2021
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julajak Limsrivilai, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536817
- Sponsor's protocol ID
- SI101/2021
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity
- ClinicalTrials.gov ID
- NCT05536817
- Acronym / sponsor ID
- SI101/2021
- Conditions
- Sleep Disorder, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 13 Sep 2022 (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.
Recently, an association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. This study aimed to investigate prevalence of poor sleep quality in IBD and association with disease activity by subjective and objective measures.
Prospective observational study is conducted with expected sample size of 100 patients. Participants are classified into active and inactive disease status according to standard IBD severity assessment measures. Demographic data, disease activity, quality of life, sleep questionnaire (validated PSQI questionaire), and seven-day sleep data acquired from ambulatory wrist actigraphy were obtained. Association between sleep quality and disease activity will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients over 18 years of age diagnosed with inflammatory bowel disease, either UC or CD. In addition, patients with non-IBD-related conditions that potentially impacted sleep quality will be excluded
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Diagnosed inflammatory bowel disease, followed up in Siriraj hospital, Mahidol University
Key exclusion criteria (6 listed)
- Unstable medical conditions
- Known psychiatric disease
- Patients who could not withhold sedative drugs
- Pregnant patients
- Obese patients with body mass index (BMI) ≥ 35 kg/m2
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
Subjective sleep quality
Time frame: 12 months
PSQI (Pittsburg sleep questionaire index) scores at first day then every month. PSQI contains ten questions, scoring provides sleep duration, latency, disturbance, efficiency, and quality. Total PSQI score of > 5 indicates poor sleep quality.
Objective sleep quality
Time frame: 12 months
Sleep efficiency (percentage of total sleep time compared to time-in-bed) provided by ambulatory wrist actigraphy on first seven consecutive days and at 12-month period. Score less than 85% is considered poor sleep quality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- 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.
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 and Inflammatory Bowel Diseases, run by Mahidol University at 1 site in Thailand.
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 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 28 Nov 2023. 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 Thailand. 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 Julajak Limsrivilai (66814968895, alimsrivilai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective sleep quality (time frame: 12 months). The study lists 2 primary outcomes in all. 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 28 Nov 2023.