Rheumatoid ArthritisNCT00287794
Quality of Sleep in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Kobe University at 1 site in Japan.
Trial summary
As one of the characteristic clinical features of the patients with rheumatoid arthritis, the unique character of the patients, somewhat difficult to be persuaded but theoretical, has long been pointed out. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- diazepam, melatonin
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2006to Dec 2010
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients with rheumatoid arthritis with or without sleep disturbance.
Who may be able to join
- Fulfilling the American College of Rheumatology criteria of rheumatoid arthritis
Who cannot join
- Any defined sleep disorders of International Classification of Sleep Disorders (ICSD)
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Konan Kakogawa Hospital
Kakogawa, Hyōgo, 675-8545
Kazuko Shiozawa, MD, PhD, +81-794-38-0621 ext. 403, Shiozawa_kkb@knc.kakogawa.or.jp
Kazuko Shiozawa, MD, PhD
About this study
Official title: Study on the Quality of Sleep in Patients With Rheumatoid Arthritis
As one of the characteristic clinical features of the patients with rheumatoid arthritis, the unique character of the patients, somewhat difficult to be persuaded but theoretical, has long been pointed out. The investigators hypothesized that this unique character might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. The investigators test (1) the sleep quality of the patients and draw some characteristic features, and (2) investigated the connection between unique biochemical changes such as the increase of c-fos or wee-1.
Read the detailed description
Under the hypothesis the unique character of patients might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. We do following studies; The study of sleep quality of the patients; The number of patients expected to be included in the study is 1,000. Inclusion criteria is the ACR criteria, and exclusion criteria is any defined disease conditions of sleep disorders in ICSD. The method includes questionnaire using the Pittsburgh Sleep Quality Index (PSQI) scoring and Epworth scoring, and actigraphy measurement for more than 3 days. In a portion of the patients, we measure clinical arthritis activities in conjunction with western blot for c-fos and wee-1 as well as routine clinical laboratory tests. Also in a portion of the patients, we do the polysomnography study; expected number of participants would be 100. We also plan to test the effect of good sloop on arthritis in a portion of the patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- diazepam, melatonin
- Keywords
- rheumatoid arthritis, sleep disturbance
- Medical subject headings
- Arthritis, Rheumatoid, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diazepam, melatoninDrug
Administration of diazepam or such drugs may improve the sleep disturbance of patients with RA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shunichi Shiozawa, MD, PhD, Study director, Faculty of Heath Science, Kobe University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287794
- Sponsor's protocol ID
- sshiozawah180206
- Status last verified
- Mar 2009
- First submitted
- 6 Feb 2006
- Last updated
- 16 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Quality of Sleep in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00287794
- Acronym / sponsor ID
- sshiozawah180206
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, sleep disturbance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 7 Feb 2006 (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.
As one of the characteristic clinical features of the patients with rheumatoid arthritis, the unique character of the patients, somewhat difficult to be persuaded but theoretical, has long been pointed out. The investigators hypothesized that this unique character might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. The investigators test (1) the sleep quality of the patients and draw some characteristic features, and (2) investigated the connection between unique biochemical changes such as the increase of c-fos or wee-1.
Detailed description
Under the hypothesis the unique character of patients might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. We do following studies; The study of sleep quality of the patients; The number of patients expected to be included in the study is 1,000. Inclusion criteria is the ACR criteria, and exclusion criteria is any defined disease conditions of sleep disorders in ICSD. The method includes questionnaire using the Pittsburgh Sleep Quality Index (PSQI) scoring and Epworth scoring, and actigraphy measurement for more than 3 days. In a portion of the patients, we measure clinical arthritis activities in conjunction with western blot for c-fos and wee-1 as well as routine clinical laboratory tests. Also in a portion of the patients, we do the polysomnography study; expected number of participants would be 100. We also plan to test the effect of good sloop on arthritis in a portion of the patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients with rheumatoid arthritis with or without sleep disturbance.
Key inclusion criteria (1 listed)
- Fulfilling the American College of Rheumatology criteria of rheumatoid arthritis
Key exclusion criteria (1 listed)
- Any defined sleep disorders of International Classification of Sleep Disorders (ICSD)
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 |
|---|---|---|
| diazepam, melatoninAdministration of diazepam or such drugs may improve the sleep disturbance of patients with RA. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2009.
- Kobe University Home PageLink provided by the sponsor.
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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.
Shunichi Shiozawa, MD, PhD study director
Faculty of Heath Science, Kobe University School of Medicine
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 Rheumatoid Arthritis, run by Kobe University at 1 site in Japan.
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 1 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 16 Mar 2009. 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 Japan. 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 Shunichi Shiozawa, MD, PhD (+81-78-382-5680 ext. direct, shioz@kobe-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 16 Mar 2009.