Registry of Central Sleep Apnea Patients Undergoing remedē System Implant (ROSTER)
The goal of this observational study is to collect information on the safety and performance of the remedē System in patients with central sleep apnea who are undergoing the remedē System implant procedure. The main question[s] it aims to answer [is/are]:
What is the incidence of serious adverse events related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant.
Participants will complete 2 home sleep apnea tests and be asked about adverse events. All other data collected will be from standard of care visits.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Samantha Bruning
- 電話番号：507-226-2953
- メール：samantha.bruning@zoll.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Subjects who are candidates to be implanted or have been implanted (but not yet been activated) with a de novo commercial remedē System implant and meet the entry criteria are eligible for inclusion in this study.
説明
Inclusion Criteria:
- Age 22 years or older
- Baseline sleep study (polysomnogram [PSG] or home sleep apnea test [HSAT]) within 2 years prior to implant indicating moderate to severe central sleep apnea. The sleep study needs to have hypopneas classified.
- Signed Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent
- In the opinion of the investigator, subject is willing and able to comply with the protocol.
- Not currently enrolled or planning to enroll in any clinical trial/study or registry that may conflict with protocol requirements or confound subject results in this study, unless approved by the sponsor
- In the opinion of the investigator, life expectancy exceeds one year
- Not pregnant or planning to become pregnant
- Has access to a smartphone
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of serious adverse events (SAEs) related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant
時間枠：From implant to 12 months post implant
|
From implant to 12 months post implant
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in central sleep apnea after 12 months of therapy
時間枠：From baseline to 12 months post therapy activation
|
Changes in central apnea hypopnea index (CAHI) |
From baseline to 12 months post therapy activation
|
|
Changes in sleep apnea after 12 months of therapy
時間枠：From baseline to 12 months post therapy activation
|
Changes in apnea hypopnea index (AHI) |
From baseline to 12 months post therapy activation
|
|
Changes in daytime sleepiness after 12 months of therapy
時間枠：From baseline to 12 months post therapy activation
|
Change in Epworth Sleepiness Scale from baseline to 12 months |
From baseline to 12 months post therapy activation
|
|
Incidence of non-serious adverse events (AEs) related to the remedē System implant procedure, device, or delivered therapy through 12 months post implant
時間枠：From implant to 12 months post implant
|
From implant to 12 months post implant
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。