Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287794
Status:
UNKNOWN
Last Update Posted:
2009-03-16
First Post:
2006-02-06
Brief Title:
Quality of Sleep in Patients With Rheumatoid Arthritis
Sponsor:
Kobe University
Organization:
Kobe University
Study Overview
Official Title:
Study on the Quality of Sleep in Patients With Rheumatoid Arthritis
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None