UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021565
Receipt number R000024864
Scientific Title Sleep apnea-related symptoms in Japanese childtren with and without Down syndrome
Date of disclosure of the study information 2016/03/22
Last modified on 2016/03/29 14:11:58

* 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

Sleep apnea-related symptoms in Japanese childtren with and without Down syndrome

Acronym

Sleep apnea-related symptoms in Japanese childtren with and without Down syndrome

Scientific Title

Sleep apnea-related symptoms in Japanese childtren with and without Down syndrome

Scientific Title:Acronym

Sleep apnea-related symptoms in Japanese childtren with and without Down syndrome

Region

Japan


Condition

Condition

Sleep apnea syndrome
Down syndrome

Classification by specialty

Cardiology Pediatrics Oto-rhino-laryngology
Nursing Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the prevalence and related factor of obstructive sleep apnea-related symptoms in Japanese children with and without Down syndrome.

Basic objectives2

Others

Basic objectives -Others

To evaluate the prevalence and related factor of obstructive sleep apnea-related symptoms in Japanese children with and without Down syndrome.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalance of sleep apnea related symptoms(snoring, nocturia, aronsal, apnea)
3% Oxigen desaturation index
Minimum oxygen saturation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment Other

Interventions/Control_1

Questionnaire investigation into about the sleep habits and having symptom and complications of sleep disordered breathing.
After that,from March, 2016 to June, 2016, we send a pulse oximeter to each family and carry out the measurement of 2 evening.

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

5 years-old <=

Age-upper limit

16 years-old >=

Gender

Male and Female

Key inclusion criteria

A Down's syndrome child, the normal child and thier caregivers who had informed about this study enough, and obtained its consent.

Key exclusion criteria

Caregivers with the severe mind growth delay and mental disease that it is difficult to cooperate with an investigation.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junji Ono

Organization

Ube frontier University

Division name

Department of nursing, Faculty of Health Science

Zip code


Address

2-1-1 Bunkyodai, Ube-City, Yamaguchi, Japan

TEL

+81-836-38-0537

Email

ono@frontier-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junji Ono

Organization

Ube frontier University

Division name

Department of nursing, Faculty of Health Science

Zip code


Address

2-1-1 Bunkyodai, Ube-City, Yamaguchi, Japan

TEL

+81-836-38-0537

Homepage URL


Email

ono@frontier-u.jp


Sponsor or person

Institute

Ube frontier University

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI Grant

Organization

Division

Category of Funding Organization

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

YES

Study ID_1

26893314

Org. issuing International ID_1

Japan Society for the Promotion of Science

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 03 Month 22 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

No longer recruiting

Date of protocol fixation

2015 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The investigation into this study content is as follows.
1.Questionnaire about symptoms of sleep disordered breathing, sleep situation and treatment experience of the sleep disordered breathing.
2. Monitoring of oxygen desaturation during sleeping.


Management information

Registered date

2016 Year 03 Month 22 Day

Last modified on

2016 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name