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Quality of Sleep in Patients With Rheumatoid Arthritis

Study on the Quality of Sleep in Patients With Rheumatoid Arthritis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00287794
Enrollment
1000
Registered
2006-02-07
Start date
2006-02-28
Completion date
2010-12-31
Last updated
2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, sleep disturbance

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.

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.

Interventions

DRUGdiazepam, melatonin

Administration of diazepam or such drugs may improve the sleep disturbance of patients with RA.

Sponsors

Kobe University
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

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)

Countries

Japan

Contacts

Primary ContactShunichi Shiozawa, MD, PhD
shioz@kobe-u.ac.jp+81-78-382-5680
Backup ContactAkira Hashiramoto, MD, PhD
hash@kobe-u.ac.jp+81-78-382-5680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026