UMIN-CTR Clinical Trial

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

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

Classification by specialty

Pneumology	Clinical immunology	Orthopedics
Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Medicine, Kyoto University

Institute

Department

Personal name

Organization

Department account fund

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Philips Respironics GK

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2016

Year

10

Month

27

Day

Last modified on

2021

Year

06

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028304