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. We 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. We 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.

Study Type: Observational

Study Design: Case-Only, Prospective

Study Primary Completion Date: December 2010

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.

Intervention(s) in this Clinical Trial

• Drug: diazepam, melatonin
  • Administration of diazepam or such drugs may improve the sleep disturbance of patients with RA.

Inclusion Criteria:

• Fulfilling the American College of Rheumatology criteria of rheumatoid arthritis

Exclusion Criteria:

• Any defined sleep disorders of International Classification of Sleep Disorders (ICSD)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 17 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kobe University

Overall Clinical Trial Officials and Contacts

Shunichi Shiozawa, MD, PhD Study Director Faculty of Heath Science, Kobe University School of Medicine  

Overall Contact: Shunichi Shiozawa, MD, PhD +81-78-796-4543 shioz@kobe-u.ac.jp

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00287794

Study ID Number: sshiozawah180206

ClinicalTrials.gov Identifier: NCT00287794

Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Kobe University Home Page

Division of Rheumatology, Kobe Univ Grad School Med