Quality of Sleep in Patients With Rheumatoid Arthritis

NCT ID: NCT00287794

Last Updated: 2009-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-12-31

Brief 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. 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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

diazepam, melatonin

Administration of diazepam or such drugs may improve the sleep disturbance of patients with RA.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kobe University

INDUSTRY

Sponsor Role: lead

Responsible Party

Kobe University Graduate Scool of Medicine

Principal Investigators

Shunichi Shiozawa, MD, PhD

Role: STUDY_DIRECTOR

Faculty of Heath Science, Kobe University School of Medicine

Locations

Konan Kakogawa Hospital

Kakogawa, Hyōgo, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Shunichi Shiozawa, MD, PhD

Role: CONTACT

shioz@kobe-u.ac.jp

+81-78-382-5680 ext. direct

Akira Hashiramoto, MD, PhD

Role: CONTACT

hash@kobe-u.ac.jp

+81-78-382-5680

Facility Contacts

Kazuko Shiozawa, MD, PhD

Role: primary

Shiozawa_kkb@knc.kakogawa.or.jp

+81-794-38-0621 ext. 403

Related Links

http://www.kobe-u.ac.jp/

Kobe University Home Page

Other Identifiers

sshiozawah180206

Identifier Type: -

Identifier Source: org_study_id