UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Trial of Tongue Stabilizing Device for Down Syndrome Patients with Obstructive Sleep Apnea
Title of the study (Brief title)	TSD trial for Down syndrome with OSA
Region	Japan

Condition
Condition	Obstructive Sleep Apnea
Classification by specialty	Medicine in general Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of tongue stabilizing device for Down syndrome patients with obstructive sleep apnea
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of 'Treatment responder' Definition of 'Treatment response': Good Adherence (use more than 70% days), and improvement of 3%ODI or OSA related symptoms
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Treatment by Tongue Stabilizing Device(TSD)
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	6 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Members of Japan Down Syndrome Society 2)Subjects with symptoms below by screening test(questionnaire and pulse oximeter) - normal level(2< for <18 years, 5< for 18<years) < 3%ODI <30 - more than one OSA related symptoms - 30<3%ODI if already failed conventional treatment such as CPAP 3) more than 6 years old Down syndrome patient with caregiver who understands and agrees with this study protocol
Key exclusion criteria	1) Subjects want conventional treatment such as CPAP or Oral appliance after screening test 2) Subject who is difficult to participate this study because of severe mental problem
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshinori Higuchi
Organization	Kyushu University Hospital
Division name	General Dentistry
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	092-642-6490
Email	higuchi@dent.kyushu-u.ac.jp

Public contact
Name of contact person	Hiroko Tsuda
Organization	Hiroko Tsuda
Division name	General Dentistry
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	092-642-6490
Homepage URL
Email	htsuda@dent.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 18 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 12 Day
Last modified on	2017 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016249