Improving the STOP-Bang Screening Questionnaire for Patients With Sleep Apnea
Improving the Sensitivity and Specificity of the STOP-Bang Screening Questionnaire for Patients With Obstructive Sleep Apnea
The study is being conducted to test the ability of a simple questionnaire to detect mild, moderate or severe obstructive sleep apnea. The investigators are also investigating whether adding the size of the neck and waist can add to the accuracy of the questionnaire.
The study will be conducted at the Center for Sleep Medicine at Tufts Medical Center. The investigators hope to enroll 250 patients in our study at Tufts Medical Center.
調査の概要
状態
詳細な説明
We will complete a 12 item questionnaire and data sheet with the study subjects based on their responses and 2 measurements specified below, right before application of a study the start of their sleep study called "Polysomnography".
If available, we will also use information from the subjects medical record, including information regarding a history of diabetes (blood sugar that is too high), high blood pressure and laboratory data such as blood sugar and blood lipids (fats in the blood). We will record this information for research purposes.
The 2 measurements performed for research purposes consist of the size of the neck and waist using a flexible tape measure. After the sleep study, we will also use results from that study in this research. We expect the subjects study participation to be completed in 30 minutes or less.
There will be no follow up. If a participant cannot complete the sleep study for any reason, the study team may decide to withdraw the subject's participation without further notice.
The study will be open for participation from June 2012 through November of 2012.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02111
- Sleep Center, Tufts Medical Center
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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
説明
Inclusion Criteria:
- Referral to the sleep center for a diagnostic study
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
コホートと介入
グループ/コホート |
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Patients presenting for a diagnostic sleep study
Patients presenting to the TMC sleep center for sleep study
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
Cut-off value determination for each of three STOP-Bang versions
時間枠:The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
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Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Apnea-Hypopnea Index AHI as defined by the society for sleep medicine.
The cut-off values will be calculated separately for each category of severity.
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The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Cut-off value determination for each of three STOP-Bang versions
時間枠:The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
|
Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Oxygen Desaturation Index ODI as defined by the Society for sleep medicine.
The cut-off values will be calculated separately for each category of severity.
|
The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Roman Schumann, MD、Tufts Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。
メタボリック・シンドロームの臨床試験
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