UMIN試験ID | UMIN000041400 |
---|---|
受付番号 | R000047265 |
科学的試験名 | 閉塞性睡眠時無呼吸症における側臥位睡眠支援装置の効果 |
一般公開日(本登録希望日) | 2020/08/13 |
最終更新日 | 2022/02/12 10:39:09 |
日本語
閉塞性睡眠時無呼吸症における側臥位睡眠支援装置の効果
英語
The effect of position therapy device on sleep parameters in patients with positional obstructive sleep apnea.
日本語
OSAにおけるPTDの効果
英語
The effect of PTD on sleep parameters in patients with POSA.
日本語
閉塞性睡眠時無呼吸症における側臥位睡眠支援装置の効果
英語
The effect of position therapy device on sleep parameters in patients with positional obstructive sleep apnea.
日本語
OSAにおけるPTDの効果
英語
The effect of PTD on sleep parameters in patients with POSA.
日本/Japan |
日本語
閉塞性睡眠時無呼吸症
英語
obstructive sleep apnea
耳鼻咽喉科学/Oto-rhino-laryngology |
悪性腫瘍以外/Others
いいえ/NO
日本語
閉塞性睡眠時無呼吸症における側臥位睡眠支援装置の終夜睡眠ポリグラフのパラメータに対する効果を検討する
英語
to investigate the effect of the postion therapy device on sleep parameters in patients with obstructive sleep apnea.
有効性/Efficacy
日本語
英語
日本語
無呼吸低呼吸指数
仰臥位睡眠時間
いびき時間
覚醒反応指数
呼吸性覚醒反応指数
自発性覚醒反応指数
睡眠効率
覚醒時間パーセンテージ
レム睡眠パーセンテージ
睡眠段階1パーセンテージ
睡眠段階2パーセンテージ
睡眠段階3パーセンテージ
英語
AHI(/h)
%supine(%)
%snoring time(%)
arousal index(/h)
respiratory arousal index(/h)
spontaneous arousal index(/h)
sleep efficiency(%)
%wake (%)
%REM(%)
%N1 (%)
%N2 (%)
%N3 (%)
日本語
英語
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
オープンだが測定者がブラインド化されている/Open -but assessor(s) are blinded
実薬・標準治療対照/Active
いいえ/NO
いいえ/NO
施設を考慮していない/Institution is not considered as adjustment factor.
いいえ/NO
準ランダム化/Pseudo-randomization
2
治療・ケア/Treatment
医療器具・機器/Device,equipment |
日本語
側臥位睡眠支援装置を装着して診断終夜睡眠ポリグラフ検査を行う
英語
position therapy device-set polysomnography(n=80)
日本語
口腔内歯科装置を装着して終夜睡眠ポリグラフ検査を行う
英語
oral appliance-set polysomnography (n=80)
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
22 | 歳/years-old | 以上/<= |
70 | 歳/years-old | 以下/>= |
男女両方/Male and Female
日本語
終夜睡眠ポリグラフ検査にて無呼吸低呼吸指数が 5 /時間以上
英語
the apnea hypopnea index score was 5 per hour or more by the PSG.
日本語
中枢性無呼吸症候群
本研究に参加意思のない者、早期CPAP療法や手術療法を望む者
口蓋扁桃肥大、鼻閉を持つ者、心不全、喘息、COPDのようなコントロールできない病気を持つ者
ナルコレプシー、パラソムニア、四肢運動障害など他の睡眠疾患を持つ者、側臥位睡眠ができない者。
英語
five or more central sleep apnea events per hour at a baseline PSG, patient not willing to cooperate ,prefer early continuous positive airway pressure or surgical treatments, evidence of tonsil hypertrophy, nasal obstruction or any diseases in the nasal cavity, uncontrolled or serious illness i.e. chronic heart failure, pulmonary disease such as asthma or chronic obstructive pulmonary disease, any other comorbid sleep disorder that would compromise functional sleep assessment ,for example, narcolepsy, parasomnia, periodic limb movement disorder, or physical problems causing inability to sleep on the side
160
日本語
名 | 雅明 |
ミドルネーム | |
姓 | 鈴木 |
英語
名 | Masaaki |
ミドルネーム | |
姓 | Suzuki |
日本語
帝京大学ちば総合医療センター
英語
Teikyo University Chiba Medical Center
日本語
耳鼻咽喉科
英語
Dept. of Otorhinolaryngology
299-0111
日本語
千葉県市原市姉崎3426-3
英語
3426-3, Anesaki, Ichihara, Chiba, JAPAN
0436-62-1211
suzukima@med.teikyo-u.ac.jp
日本語
名 | 雅明 |
ミドルネーム | |
姓 | 鈴木 |
英語
名 | Masaaki |
ミドルネーム | |
姓 | Suzuki |
日本語
帝京大学ちば総合医療センター
英語
Teikyo University Chiba Medical Center
日本語
耳鼻咽喉科
英語
Dept. of Otorhinolaryngology
299-0111
日本語
千葉県市原市姉崎3426-3
英語
3426-3, Anesaki, Ichihara, Chiba, JAPAN
0436-62-1211
suzukima@med.teikyo-u.ac.jp
日本語
帝京大学
英語
Teikyo University
日本語
日本語
日本語
英語
日本語
帝京大学
英語
Teikyo University
日本語
日本語
自己調達/Self funding
日本語
英語
日本語
英語
日本語
英語
日本語
帝京大学倫理委員会
英語
Teikyo University IRB
日本語
東京都板橋区加賀2丁目11-1
英語
2-11-1, Kaga, Itabashi-ku, Tokyo, JAPAN
03-3964-7256
turb-office@teikyo-u.ac.jp
いいえ/NO
日本語
英語
日本語
英語
2020 | 年 | 08 | 月 | 13 | 日 |
https://link.springer.com/article/10.1007/s00405-021-06817-2
未公表/Unpublished
https://link.springer.com/article/10.1007/s00405-021-06817-2
160
日本語
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
英語
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
2022 | 年 | 02 | 月 | 12 | 日 |
日本語
英語
日本語
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
英語
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
日本語
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
英語
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
日本語
None
英語
None
日本語
he PTD decreased the AHI from a mean of 24.2 to 16.7/h, and the OA decreased the AHI from 20.8 to 10.3/h. Percentage of snoring time decreased from 31.1 to 16.9 % in the PTD group, and from 41.2 to 30.7% in the OA group. There were no significant decreases between the two groups. The PTD decreased sleep-time percentage in the supine position from a mean of 67.4 to 4.5%, despite 5 patients who were unable to avoid the supine position. There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
英語
he PTD decreased the AHI from a mean of 24.2 to 16.7/h, and the OA decreased the AHI from 20.8 to 10.3/h. Percentage of snoring time decreased from 31.1 to 16.9 % in the PTD group, and from 41.2 to 30.7% in the OA group. There were no significant decreases between the two groups. The PTD decreased sleep-time percentage in the supine position from a mean of 67.4 to 4.5%, despite 5 patients who were unable to avoid the supine position. There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
日本語
英語
日本語
英語
一般募集中/Open public recruiting
2019 | 年 | 09 | 月 | 01 | 日 |
2019 | 年 | 09 | 月 | 25 | 日 |
2019 | 年 | 09 | 月 | 25 | 日 |
2020 | 年 | 12 | 月 | 31 | 日 |
日本語
英語
2020 | 年 | 08 | 月 | 12 | 日 |
2022 | 年 | 02 | 月 | 12 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047265
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047265
研究計画書 | |
---|---|
登録日時 | ファイル名 |
研究症例データ仕様書 | |
---|---|
登録日時 | ファイル名 |
研究症例データ | |
---|---|
登録日時 | ファイル名 |