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Quality of Sleep in Patients With Rheumatoid Arthritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Kobe University.
Recruitment status was:  Recruiting
Information provided by:
Kobe University Identifier:
First received: February 6, 2006
Last updated: March 13, 2009
Last verified: March 2009
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.

Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00287794

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

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

Additional Information:
Responsible Party: Shunichi Shiozawa MD, Kobe University Graduate Scool of Medicine Identifier: NCT00287794     History of Changes
Other Study ID Numbers: sshiozawah180206
Study First Received: February 6, 2006
Last Updated: March 13, 2009

Keywords provided by Kobe University:
rheumatoid arthritis
sleep disturbance

Additional relevant MeSH terms:
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
Anesthetics processed this record on September 20, 2017