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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027645
Receipt No. R000031669
Scientific Title Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Date of disclosure of the study information 2017/06/05
Last modified on 2019/06/12

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Basic information
Public title Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Acronym Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Scientific Title Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Scientific Title:Acronym Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Region
Japan

Condition
Condition Sleep Apnea Syndrome
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Suvorexant is a sleeping drug without sedation, it is expected to be safe for a case having respiratory illnesses safely. There is a report that Suvorexant doesn't have any influence to a sleeping apnea hypopnea index of OSAS and the COPD case of the medium grade symptom. However, there are few report about using Suvorexant for severe OSAS(more than AHI 30) and severe COPD.
The aim of this study is to examine influence on sleep and breathing, and to identify safety of using orexin receptor antagonist Suvorexant for severe OSAS case.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change on the PSG data before and after the single using of orexin receptor antagonist Suvorexant 15 mg
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
Medicine
Interventions/Control_1 Control group: first night of PSG result
Interventions group: second night of PSG result(using with Suvorexant 15mg)
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

Not applicable
Gender Male and Female
Key inclusion criteria The patient who received enough explanation about this study, and provides agreement in the document.
Key exclusion criteria The patient 19 years or younger at the time of the agreement acquisition
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuyoshi
Middle name
Last name Imaizumi
Organization Fujita Health University
Division name Respiratory medicine department
Zip code 470-1192
Address 1-98, Dengakugakubo, Kustukake Cho, Toyoake City, Aichi, Japan
TEL +81-0562-93-9241
Email mienon@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Mieno
Organization Fujita Health University
Division name Respiratory medicine department
Zip code 470-1192
Address 1-98, Dengakugakubo, Kustukake Cho, Toyoake City, Aichi, Japan
TEL +81-0562-93-9241
Homepage URL
Email mienon@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University respiratory medicine department
Institute
Department

Funding Source
Organization Fujita Health University respiratory medicine department
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fujita Health University Institutional review board
Address 1-98, Dengakugakubo, Kustukake Cho, Toyoake City, Aichi, Japan
Tel +81-0562-93-2865
Email f-irb@fujita-hu.ac.jp

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 藤田医科大学(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 05 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 30 Day
Date of IRB
2016 Year 10 Month 28 Day
Anticipated trial start date
2016 Year 11 Month 15 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 05 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031669

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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