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 |
Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Clinical study about the safety of Orexin receptor antagonist Suvorexant for severe sleep apnea syndrome
Japan |
Sleep Apnea Syndrome
Pneumology |
Others
NO
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.
Safety
Confirmatory
Change on the PSG data before and after the single using of orexin receptor antagonist Suvorexant 15 mg
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Control group: first night of PSG result
Interventions group: second night of PSG result(using with Suvorexant 15mg)
20 | years-old | <= |
Not applicable |
Male and Female
The patient who received enough explanation about this study, and provides agreement in the document.
The patient 19 years or younger at the time of the agreement acquisition
30
1st name | Kazuyoshi |
Middle name | |
Last name | Imaizumi |
Fujita Health University
Respiratory medicine department
470-1192
1-98, Dengakugakubo, Kustukake Cho, Toyoake City, Aichi, Japan
+81-0562-93-9241
mienon@fujita-hu.ac.jp
1st name | Yuki |
Middle name | |
Last name | Mieno |
Fujita Health University
Respiratory medicine department
470-1192
1-98, Dengakugakubo, Kustukake Cho, Toyoake City, Aichi, Japan
+81-0562-93-9241
mienon@fujita-hu.ac.jp
Fujita Health University respiratory medicine department
Fujita Health University respiratory medicine department
Self funding
Fujita Health University Institutional review board
1-98, Dengakugakubo, Kustukake Cho, Toyoake City, Aichi, Japan
+81-0562-93-2865
f-irb@fujita-hu.ac.jp
NO
藤田医科大学(愛知県)
2017 | Year | 06 | Month | 05 | Day |
Unpublished
30
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.
2021 | Year | 06 | Month | 08 | Day |
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.
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.
There has been no outbreak of disease related to this clinical research.
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.
Completed
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 10 | Month | 28 | Day |
2016 | Year | 11 | Month | 15 | Day |
2021 | Year | 07 | Month | 31 | Day |
2017 | Year | 06 | Month | 05 | Day |
2021 | Year | 12 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031669