Quality of Sleep in Patients With Rheumatoid Arthritis

Sponsor
Kobe University (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00287794
Collaborator
(none)
1,000
1
58
17.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: diazepam, melatonin

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

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Study on the Quality of Sleep in Patients With Rheumatoid Arthritis
Study Start Date :
Feb 1, 2006
Anticipated Primary Completion Date :
Dec 1, 2010
Anticipated Study Completion Date :
Dec 1, 2010

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konan Kakogawa Hospital Kakogawa Hyogo Japan 675-8545

    Sponsors and Collaborators

    • Kobe University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00287794
    Other Study ID Numbers:
    • sshiozawah180206
    First Posted:
    Feb 7, 2006
    Last Update Posted:
    Mar 16, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2009