UMIN-CTR Clinical Trial

Basic information
Public title	The impact of treating rheumatoid arthritis on sleep
Acronym	The impact of treating rheumatoid arthritis on sleep
Scientific Title	The impact of treating rheumatoid arthritis on sleep
Scientific Title:Acronym	The impact of treating rheumatoid arthritis on sleep
Region	Japan

Condition
Condition	Rheumatoid arthritis (RA), Obstructive sleep apnea (OSA)
Classification by specialty	Pneumology Clinical immunology Orthopedics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the impact of treating RA on sleep longitudinally.
Basic objectives2	Others
Basic objectives -Others	To explore the prevalence and degree of sleep disturbance including sleep duration in patients with RA.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The score of Pittsburgh Sleep Quality Index (PSQI) of before and after treatment in patients with RA
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toyohiro Middle name Last name Hirai
Organization	Kyoto University Hospital
Division name	Respiratory Medicine
Zip code	6068507
Address	54 Shogoin-Kawaracho Sakyo-ku Kyoto
TEL	075-751-3830
Email	t_hirai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Takuma Middle name Last name Minami
Organization	Graduate School of Medicine, Kyoto University
Division name	Respiratory medicine
Zip code	6068507
Address	Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto
TEL	075-751-3830
Homepage URL
Email	t.373@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Department account fund
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Philips Respironics GK

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4642
Email	ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date	2016 Year 11 Month 07 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Prospective observational study The changes of the above mentioned outcomes before, immediately and three months after treatment of RA will be investigated. Questionnaires, laboratory data and psychomotor vigilance task will be evaluated before and three months after treatment of RA. When patients are diagnosed as OSA and have CPAP therapy, these outcomes will be evaluated before and three months after therapy.

Management information
Registered date	2016 Year 10 Month 27 Day
Last modified on	2021 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028304