Quality of Sleep in Patients With Rheumatoid Arthritis

NCT00287794 | Unknown

• 1 other identifier: sshiozawah180206
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; sleep disturbance

Interventions

diazepam, melatonin DRUG

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

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients with rheumatoid arthritis with or without sleep disturbance.

You may qualify if:

• Fulfilling the American College of Rheumatology criteria of rheumatoid arthritis

You may not qualify if:

• Any defined sleep disorders of International Classification of Sleep Disorders (ICSD)

Sponsors & Collaborators

• Kobe University: lead

Study Sites (1)

Konan Kakogawa Hospital

Kakogawa, Hyōgo, 675-8545, Japan

RECRUITING

Related Links

• Kobe University Home Page

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples for Western blot for inflammatory cytokines and transcription factors responsible for arthritis.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Parasomnias

Interventions

Diazepam; Melatonin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Shunichi Shiozawa, MD, PhD

  Faculty of Heath Science, Kobe University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Shunichi Shiozawa, MD, PhD

CONTACT

+81-78-382-5680; shioz@kobe-u.ac.jp

Akira Hashiramoto, MD, PhD

CONTACT

+81-78-382-5680; hash@kobe-u.ac.jp

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 16, 2009

Record last verified: 2009-03

Locations

JP (1)