UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021825
Receipt number R000025149
Scientific Title The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease
Date of disclosure of the study information 2016/05/01
Last modified on 2019/02/27 13:17:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

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

Condition

Obstructive sleep apnea (OSA)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


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 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


Research contact person

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


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 or person

Institute

Graduate school of medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor, and Welfare of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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 05 Month 01 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

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

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.


Management information

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name