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| Sponsored by: |
Kobe University |
|---|---|
| Information provided by: | Kobe University |
| ClinicalTrials.gov Identifier: | NCT00287794 |
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 I |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Study on the Quality of Sleep in Patients With Rheumatoid Arthritis |
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) |
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 |
All the patients with rheumatoid arthritis with or without sleep disturbance.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| Japan, Hyogo | |
| 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 | |
| Study Director: | Shunichi Shiozawa, MD, PhD | Faculty of Heath Science, Kobe University School of Medicine |
More Information
| Responsible Party: | Kobe University Graduate Scool of Medicine ( Shunichi Shiozawa MD ) |
| Study ID Numbers: | sshiozawah180206 |
| Study First Received: | February 6, 2006 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00287794 History of Changes |
| Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
|
rheumatoid arthritis sleep disturbance |
|
Neurotransmitter Agents Arthritis, Rheumatoid Psychotropic Drugs Anesthetics Sleep Disorders Antiemetics Musculoskeletal Diseases Arthritis Muscle Relaxants, Central Hypnotics and Sedatives Connective Tissue Diseases Melatonin Anesthetics, Intravenous |
Autoimmune Diseases Tranquilizing Agents Diazepam Joint Diseases Adjuvants, Immunologic Dyssomnias Central Nervous System Depressants Rheumatic Diseases Anesthetics, General Anti-Anxiety Agents Peripheral Nervous System Agents Anticonvulsants |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Arthritis, Rheumatoid Anesthetics Antiemetics Neuromuscular Agents Musculoskeletal Diseases Therapeutic Uses Arthritis Muscle Relaxants, Central Hypnotics and Sedatives Connective Tissue Diseases |
Anesthetics, Intravenous Autoimmune Diseases Tranquilizing Agents Immune System Diseases Diazepam Joint Diseases Gastrointestinal Agents Central Nervous System Depressants Rheumatic Diseases Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Autonomic Agents GABA Agents Anti-Anxiety Agents |
