UMIN-CTR Clinical Trial

Public title

The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease

Acronym

The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease

Scientific Title

The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease

Scientific Title:Acronym

The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease

Region

Japan

Condition

Obstructive sleep apnea (OSA)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore the association and the influence to lifestyle disease between daily activity of patients suspected to have sleep related breathing disorders and sleep disturbance focusing on sleep apnea.

Basic objectives2

Others

Basic objectives -Others

To validate the measurement of sleep time by actiwatch2 compared to PSG for patients with sleep related breathing disorder.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease

Key secondary outcomes

To validate the measurement of sleep duration by Actiwatch 2 compared with PSG according to severity of sleep related breathing disorders.
To validate that UW-301BT can measure sleep disturbance including sleep duration and daily activity, compared with Actiwatch 2 and Lifecorder.

To explore the association among following items, OSA severity, sleep duration and daily activity

1) 3%ODI measured by Pulsox and Actiwatch 2 or UW-301BT
2) Sleep disturbance and activity measured by Actiwatch 2 and UW-301BT
3) Physical activity measured by Lifecorder and UW-301BT
4) Body weight and body composition
5) Sleep quality
6) Questionaires
7) Laboratory tests and urinalysis
8) Arterial blood gases
9) Visceral fat
10) Electrocardiography
11) Lung function test
12) Chest X ray
13) Vascular endothelial function measured by Endo-PAT

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 with this study

Key exclusion criteria

# Patients who are suspected to have other sleep related breathing disorders except for OSA and scheduled to undergo PSG
# Patients have difficulty with wearing measuring equipment due to dementia, physically handicapped, and so on
# Patients who is considered as unfit by a main researcher

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo Chin

Organization

Graduate school of medicine, Kyoto University

Division name

Department of Respiratory Care and Sleep Control Medicine

Zip code

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan

TEL

075-751-3852

Email

chink@kuhp.kyoto-u.ac.jp

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

Institute

Graduate school of medicine, Kyoto University

Institute

Department

Personal name

Organization

Ministry of Health, Labor, and Welfare of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

05

Month

01

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

Terminated

Date of protocol fixation

2016

Year

03

Month

29

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

18

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Cross-sectional study ; descriptive epidemiology

Patients suspected to have OSA equip Lifecorder, Actiwatch 2 and UW-301BT the whole day and keep a sleep diary consecutive for 7 days. They also equip Pulsox during sleep for 2 days to measure Oxygen desaturation index; ODI.

If patients have the indication of polysomnography from the 3% ODI, they do one night PSG in the hospital with Actiwatch 2 and Pulsox. They have usual laboratory tests and urinalysis.

Registered date

2016

Year

04

Month

07

Day

Last modified on

2019

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025149