UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027645 |
|---|---|
| Receipt number | 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 | 2021/12/08 19:57:35 |
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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
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
mienon@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University respiratory medicine department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031669
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
