Quality of Sleep in Patients With Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Kobe University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kobe University
ClinicalTrials.gov Identifier:
NCT00287794
First received: February 6, 2006
Last updated: March 13, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: diazepam, melatonin
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study on the Quality of Sleep in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Kobe University:

Biospecimen Retention:   Samples Without DNA

Samples for Western blot for inflammatory cytokines and transcription factors responsible for arthritis.


Estimated Enrollment: 1000
Study Start Date: February 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: diazepam, melatonin
    Administration of diazepam or such drugs may improve the sleep disturbance of patients with RA.
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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All the patients with rheumatoid arthritis with or without sleep disturbance.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287794

Contacts
Contact: Shunichi Shiozawa, MD, PhD +81-78-382-5680 ext direct shioz@kobe-u.ac.jp
Contact: Akira Hashiramoto, MD, PhD +81-78-382-5680 hash@kobe-u.ac.jp

Locations
Japan
Konan Kakogawa Hospital Recruiting
Kakogawa, Hyogo, Japan, 675-8545
Contact: Kazuko Shiozawa, MD, PhD    +81-794-38-0621 ext 403    Shiozawa_kkb@knc.kakogawa.or.jp   
Principal Investigator: Kazuko Shiozawa, MD, PhD         
Sponsors and Collaborators
Kobe University
Investigators
Study Director: Shunichi Shiozawa, MD, PhD Faculty of Heath Science, Kobe University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Shunichi Shiozawa MD, Kobe University Graduate Scool of Medicine
ClinicalTrials.gov Identifier: NCT00287794     History of Changes
Other Study ID Numbers: sshiozawah180206
Study First Received: February 6, 2006
Last Updated: March 13, 2009
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kobe University:
rheumatoid arthritis
sleep disturbance

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014