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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024595
Receipt No. R000028304
Scientific Title The impact of treating rheumatoid arthritis on sleep
Date of disclosure of the study information 2016/11/07
Last modified on 2017/11/27

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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
Middle name
Last name Toyohiro Hirai
Organization Kyoto University Hospital
Division name Respiratory Medicine
Zip code
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
Middle name
Last name Takuma Minami
Organization Graduate School of Medicine, Kyoto University
Division name Respiratory medicine
Zip code
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
Address
Tel
Email

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
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
2017 Year 11 Month 27 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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