UMIN-CTR 臨床試験登録情報の閲覧

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

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information

一般向け試験名/Public title

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.

一般向け試験名略称/Acronym

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.

科学的試験名/Scientific Title

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.

科学的試験名略称/Scientific Title:Acronym

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.

試験実施地域/Region

日本/Japan


対象疾患/Condition

対象疾患名/Condition

日本語
閉塞性睡眠時無呼吸症


英語
obstructive sleep apnea

疾患区分1/Classification by specialty

耳鼻咽喉科学/Oto-rhino-laryngology

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO


目的/Objectives

目的1/Narrative objectives1

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.

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語


英語

試験の性質1/Trial characteristics_1


試験の性質2/Trial characteristics_2


試験のフェーズ/Developmental phase



評価/Assessment

主要アウトカム評価項目/Primary outcomes

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 (%)

副次アウトカム評価項目/Key secondary outcomes

日本語


英語


基本事項/Base

試験の種類/Study type

介入/Interventional


試験デザイン/Study design

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

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

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

いいえ/NO

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

いいえ/NO

割付コードを知る方法/Concealment

準ランダム化/Pseudo-randomization


介入/Intervention

群数/No. of arms

2

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

医療器具・機器/Device,equipment

介入1/Interventions/Control_1

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)

介入2/Interventions/Control_2

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)

介入3/Interventions/Control_3

日本語


英語

介入4/Interventions/Control_4

日本語


英語

介入5/Interventions/Control_5

日本語


英語

介入6/Interventions/Control_6

日本語


英語

介入7/Interventions/Control_7

日本語


英語

介入8/Interventions/Control_8

日本語


英語

介入9/Interventions/Control_9

日本語


英語

介入10/Interventions/Control_10

日本語


英語


適格性/Eligibility

年齢(下限)/Age-lower limit

22 歳/years-old 以上/<=

年齢(上限)/Age-upper limit

70 歳/years-old 以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

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.

除外基準/Key exclusion criteria

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

目標参加者数/Target sample size

160


責任研究者/Research contact person

責任研究者/Name of lead principal investigator

日本語
雅明
ミドルネーム
鈴木


英語
Masaaki
ミドルネーム
Suzuki

所属組織/Organization

日本語
帝京大学ちば総合医療センター


英語
Teikyo University Chiba Medical Center

所属部署/Division name

日本語
耳鼻咽喉科


英語
Dept. of Otorhinolaryngology

郵便番号/Zip code

299-0111

住所/Address

日本語
千葉県市原市姉崎3426-3


英語
3426-3, Anesaki, Ichihara, Chiba, JAPAN

電話/TEL

0436-62-1211

Email/Email

suzukima@med.teikyo-u.ac.jp


試験問い合わせ窓口/Public contact

試験問い合わせ窓口担当者/Name of contact person

日本語
雅明
ミドルネーム
鈴木


英語
Masaaki
ミドルネーム
Suzuki

組織名/Organization

日本語
帝京大学ちば総合医療センター


英語
Teikyo University Chiba Medical Center

部署名/Division name

日本語
耳鼻咽喉科


英語
Dept. of Otorhinolaryngology

郵便番号/Zip code

299-0111

住所/Address

日本語
千葉県市原市姉崎3426-3


英語
3426-3, Anesaki, Ichihara, Chiba, JAPAN

電話/TEL

0436-62-1211

試験のホームページURL/Homepage URL


Email/Email

suzukima@med.teikyo-u.ac.jp


実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
帝京大学


英語
Teikyo University

機関名/Institute
(機関選択不可の場合)

日本語


部署名/Department

日本語


個人名/Personal name

日本語


英語


研究費提供組織/Funding Source

機関名/Organization

日本語
帝京大学


英語
Teikyo University

機関名/Organization
(機関選択不可の場合)

日本語


組織名/Division

日本語


組織の区分/Category of Funding Organization

自己調達/Self funding

研究費拠出国/Nationality of Funding Organization

日本語


英語


その他の関連組織/Other related organizations

共同実施組織/Co-sponsor

日本語


英語

その他の研究費提供組織/Name of secondary funder(s)

日本語


英語


IRB等連絡先(公開)/IRB Contact (For public release)

組織名/Organization

日本語
帝京大学倫理委員会


英語
Teikyo University IRB

住所/Address

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

電話/Tel

03-3964-7256

Email/Email

turb-office@teikyo-u.ac.jp


他機関から発行された試験ID/Secondary IDs

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1


ID発行機関1/Org. issuing International ID_1

日本語


英語

試験ID2/Study ID_2


ID発行機関2/Org. issuing International ID_2

日本語


英語

治験届/IND to MHLW



試験実施施設/Institutions

試験実施施設名称/Institutions



その他の管理情報/Other administrative information

一般公開日(本登録希望日)/Date of disclosure of the study information

2020 08 13


関連情報/Related information

プロトコル掲載URL/URL releasing protocol

https://link.springer.com/article/10.1007/s00405-021-06817-2

試験結果の公開状況/Publication of results

未公表/Unpublished


結果/Result

結果掲載URL/URL related to results and publications

https://link.springer.com/article/10.1007/s00405-021-06817-2

組み入れ参加者数/Number of participants that the trial has enrolled

160

主な結果/Results

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.

主な結果入力日/Results date posted

2022 02 12

結果掲載遅延/Results Delayed


結果遅延理由/Results Delay Reason

日本語


英語

最初の試験結果の出版日/Date of the first journal publication of results


参加者背景/Baseline Characteristics

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.

参加者の流れ/Participant flow

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.

有害事象/Adverse events

日本語
None


英語
None

評価項目/Outcome measures

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.

個別症例データ共有計画/Plan to share IPD

日本語


英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語


英語


試験進捗状況/Progress

試験進捗状況/Recruitment status

一般募集中/Open public recruiting

プロトコル確定日/Date of protocol fixation

2019 09 01

倫理委員会による承認日/Date of IRB

2019 09 25

登録・組入れ開始(予定)日/Anticipated trial start date

2019 09 25

フォロー終了(予定)日/Last follow-up date

2020 12 31

入力終了(予定)日/Date of closure to data entry


データ固定(予定)日/Date trial data considered complete


解析終了(予定)日/Date analysis concluded



その他/Other

その他関連情報/Other related information

日本語


英語


管理情報/Management information

登録日時/Registered date

2020 08 12

最終更新日/Last modified on

2022 02 12



閲覧ページへのリンク/Link to view the page

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