The impact of treating rheumatoid arthritis on sleep

The impact of treating rheumatoid arthritis on sleep - The impact of treating rheumatoid arthritis on sleep

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024595

Enrollment

100

Registered

2016-11-07

Start date

2016-11-07

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Rheumatoid arthritis (RA), Obstructive sleep apnea (OSA)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who agree to participate in this study and meet the followings conditions: #1 Untreated RA patients who are scheduled to start treatment for RA #2 RA patients who are scheduled to start methotraxate for the first time #3 RA patients who are scheduled to start biological agents for the first time #4 RA patients who have had treatment with biological agents and are scheduled to resume biological agents #5 RA patients who are under treatment with biological agents and scheduled to switch to other biological agents

Exclusion criteria

Exclusion criteria: # Patients who have difficulty with wearing measuring equipment due to dementia, physically handicapped, and so on # Patients who have had treatment with methotrexate in the past and the present treatment will be re-admininstration of methotraxate # Patients who is considered as inappropriate by a main researcher

Design outcomes

Primary

Measure	Time frame
The score of Pittsburgh Sleep Quality Index (PSQI) of before and after treatment in patients with RA	—

Secondary

Measure	Time frame
1. Sleep duration 2. The index of sleep disturbance (wake after sleep onset, sleep efficiency, sleep fragmentation, sleep latency, peripheral artery tonometry apnea hypopnea index, 3 and 4% oxygen desaturation index, time spent with SpO2 below 90%, the lowest SpO2, sleep stage) 3. Questionnaires including quality of life (Japan-Epworth Sleepiness Scale, Medical Outcomes Study 36-Item Short Form Health Survey, Hospital Anxiety and Depression Scale, Physical Activity, The Berline Questionnaire) 4. The prevalence of OSA 5. The prevalence of restless leg syndrome 6. The disease activity of RA 7. Psychomotor vigilance task 8. Physical activity measured by life coda and actiwatch 9. Blood sample including inflammatory cytokines and matrix metalloproteinase, urinalysis 10. Pulmonary function test 11. X ray, chest CT 12. Vascular endothelial function	—

Measure

Time frame

1. Sleep duration 2. The index of sleep disturbance (wake after sleep onset, sleep efficiency, sleep fragmentation, sleep latency, peripheral artery tonometry apnea hypopnea index, 3 and 4% oxygen desaturation index, time spent with SpO2 below 90%, the lowest SpO2, sleep stage) 3. Questionnaires including quality of life (Japan-Epworth Sleepiness Scale, Medical Outcomes Study 36-Item Short Form Health Survey, Hospital Anxiety and Depression Scale, Physical Activity, The Berline Questionnaire) 4. The prevalence of OSA 5. The prevalence of restless leg syndrome 6. The disease activity of RA 7. Psychomotor vigilance task 8. Physical activity measured by life coda and actiwatch 9. Blood sample including inflammatory cytokines and matrix metalloproteinase, urinalysis 10. Pulmonary function test 11. X ray, chest CT 12. Vascular endothelial function

—

Countries

Japan

Contacts

Public ContactTakuma Minami

Graduate School of Medicine, Kyoto University Respiratory medicine

t.373@kuhp.kyoto-u.ac.jp075-751-3830

Outcome results