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Quality of Sleep in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287794
Recruitment Status : Unknown
Verified March 2009 by Kobe University.
Recruitment status was:  Recruiting
First Posted : February 7, 2006
Last Update Posted : March 16, 2009
Information provided by:
Kobe University

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
Rheumatoid Arthritis 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.

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Study Type : Observational
Estimated 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 : February 2006
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

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

Biospecimen Retention:   Samples Without DNA
Samples for Western blot for inflammatory cytokines and transcription factors responsible for arthritis.

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the patients with rheumatoid arthritis with or without sleep disturbance.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287794

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Contact: Shunichi Shiozawa, MD, PhD +81-78-382-5680 ext direct
Contact: Akira Hashiramoto, MD, PhD +81-78-382-5680

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Konan Kakogawa Hospital Recruiting
Kakogawa, Hyogo, Japan, 675-8545
Contact: Kazuko Shiozawa, MD, PhD    +81-794-38-0621 ext 403   
Principal Investigator: Kazuko Shiozawa, MD, PhD         
Sponsors and Collaborators
Kobe University
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Study Director: Shunichi Shiozawa, MD, PhD Faculty of Heath Science, Kobe University School of Medicine
Additional Information:
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Responsible Party: Shunichi Shiozawa MD, Kobe University Graduate Scool of Medicine Identifier: NCT00287794    
Other Study ID Numbers: sshiozawah180206
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009
Keywords provided by Kobe University:
rheumatoid arthritis
sleep disturbance
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Adjuvants, Anesthesia
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General