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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- Sleep Center, Tufts Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Referral to the sleep center for a diagnostic study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Cut-off value determination for each of three STOP-Bang versions
Délai: 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.
|
The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cut-off value determination for each of three STOP-Bang versions
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Roman Schumann, MD, Tufts Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système nerveux
- Maladies des voies respiratoires
- Troubles respiratoires
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Troubles du sommeil et de l'éveil
- Signes et symptômes respiratoires
- Résistance à l'insuline
- Hyperinsulinisme
- Syndromes d'apnée du sommeil
- Apnée
- Syndrome métabolique
Autres numéros d'identification d'étude
- IRB#10391
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