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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021565
Receipt No. 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

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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
Institute Ube frontier University
Institute
Department

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
URL(English) https://upload.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


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