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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014723
Receipt No. R000017028
Scientific Title Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome: multicenter, open label, prospective randomized non-inferiority crossover trial
Date of disclosure of the study information 2014/08/01
Last modified on 2018/08/03

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Basic information
Public title Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome: multicenter, open label, prospective randomized non-inferiority crossover trial
Acronym Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome
Scientific Title Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome: multicenter, open label, prospective randomized non-inferiority crossover trial
Scientific Title:Acronym Comparison of endothelial function with the mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) among patients with moderate sleep apnea syndrome
Region
Japan

Condition
Condition Sleep apnea syndrome
Classification by specialty
Cardiology Psychiatry Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effectiveness of MAD (Somnodent®) and the continuous positive airway pressure (CPAP) on the cardiovascular system by comparing the changes in endothelial function measured by flow-mediated dilatation (FMD) among patients with moderate sleep apnea syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The degree of change in FMD at the end of each course of therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 treat with CPAP then treat with MAD
Interventions/Control_2 treat with MAD then treat with CPAP
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

Not applicable
Gender Male and Female
Key inclusion criteria 1: >20 years of age
2: 20<AHI<=40 by full polysomnography study
3: With two criteria for OSAS symptoms
4: With postural dependency defined as (AHI of supine position > 2 times AHI during sleeping position other than supine)
Key exclusion criteria 1. History of treatment of OSAS
2. Patients who needs to treat immediately
3. With central sleep apnea dominance (CAHI>5)
4. With insomnia or hypersomnia not relate to OSAS
5. Using sedatives,
6. With pulmonary (asthma, COPD etc.) or mental disease which needs to treat
7. Unable to fit MAD
8. With coronary heart disease and cerebrovascular disease
9. On hemodialysis
10. Patients who are judged unsuitable to participate in the study by the attending physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichi Ando
Organization Kyushu university hospital
Division name Sleep Apnea Center
Zip code
Address 3-1-1 Maidashi Higashiku Fukuoka Japan
TEL 093-642-5987
Email shinando@sleep.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ichi Ando
Organization Kyushu university hospital
Division name Sleep Apnea Center
Zip code
Address 3-1-1 Maidashi Higashiku Fukuoka Japan
TEL 093-642-5987
Homepage URL
Email shinando@sleep.med.kyushu-u.ac.jp

Sponsor
Institute Sleep apnea center,Kyushu university hospital
Institute
Department

Funding Source
Organization sleep apnea center,Kyushu university hospital
Organization
Division
Category of Funding Organization Other
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
2014 Year 08 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 Completed
Date of protocol fixation
2013 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2017 Year 01 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 31 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017028

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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