Trial record 3 of 47 for:
Parasomnias | ( Map: Japan )
Quality of Sleep in Patients With Rheumatoid Arthritis
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| ClinicalTrials.gov Identifier: NCT00287794 |
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Recruitment Status : Unknown
Verified March 2009 by Kobe University.
Recruitment status was: Recruiting
First Posted : February 7, 2006
Last Update Posted : March 16, 2009
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Sponsor:
Kobe University
Information provided by:
Kobe University
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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 |
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 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
Genetics Home Reference related topics:
Rheumatoid arthritis
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.
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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.
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)
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 ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| Responsible Party: | Shunichi Shiozawa MD, Kobe University Graduate Scool of Medicine |
| ClinicalTrials.gov Identifier: | NCT00287794 History of Changes |
| 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:
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rheumatoid arthritis sleep disturbance |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Melatonin Diazepam Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |
Adjuvants, Anesthesia Anticonvulsants Antiemetics 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 |