UMIN-CTR Clinical Trial

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	30
Results	There is no significant difference in AHI (median: 48.3 times/hour on the first night, 50.2 times/hour on the second night p=0.58). Among the secondary endpoints, significant differences were found in sleep efficiency (median: 82.8% on first night, 87.8% on second night, p=0.004), REM sleep rate (median: 15.0% on first night, 21.2% on second night, p<0.001). There was no significant difference in the AHI of patients with severe sleep apnea before and after taking Suvorexant.
Results date posted	2021 Year 06 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Of the adult patients who gave written consent to participate in the study, 30 patients (20 males and 5 females, median age 55 (50.8-60.8) years, median Body Mass Index 26.3 (24.8-29) kg/m2, median AHI 41.6-61.4)times/h) (37.1-61.4) times/hour) with AHI >30 times/hour on the first day of the study were included.
Participant flow	We enrolled 30 patients(20 males and 5 females, median age 55 years). The adult patients who were scheduled for a 2-nights polysomnography (PSG) examination at Fujita Medical University Hospital and gave written consent to participate in the study, patients with severe OSA on the first night of the examination were included. The primary endpoint was AHI.
Adverse events	There has been no outbreak of disease related to this clinical research.
Outcome measures	The primary endpoint was the AHI, and secondary endpoints were the lowest saturation of percutaneous oxygen (SpO2), SpO2 <90% time, sleep efficiency, sleep stages, arousal index, and sleep latency.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2021 Year 12 Month 08 Day

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