Quality of Sleep in Patients With Rheumatoid Arthritis
Information source: Kobe University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: diazepam, melatonin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Kobe University Official(s) and/or principal investigator(s):
Shunichi Shiozawa, MD, PhD, Study Director, Affiliation: Faculty of Heath Science, Kobe University School of Medicine
Overall contact:
Shunichi Shiozawa, MD, PhD, Phone: +81-78-382-5680, Ext: direct, Email: shioz@kobe-u.ac.jp
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.
Clinical Details
Official title: Study on the Quality of Sleep in Patients With Rheumatoid Arthritis
Study design: Case-Only, Prospective
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.
Eligibility
Minimum age: 17 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Shunichi Shiozawa, MD, PhD, Phone: +81-78-382-5680, Ext: direct, Email: shioz@kobe-u.ac.jp
Konan Kakogawa Hospital, Kakogawa, Hyogo 675-8545, Japan; Recruiting
Kazuko Shiozawa, MD, PhD, Phone: +81-794-38-0621, Ext: 403, Email: Shiozawa_kkb@knc.kakogawa.or.jp
Kazuko Shiozawa, MD, PhD, Principal Investigator
Additional Information
Kobe University Home Page Division of Rheumatology, Kobe Univ Grad School Med
Starting date: February 2006
Ending date: December 2010
Last updated: March 13, 2009
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