Improving the STOP-Bang Screening Questionnaire for Patients With Sleep Apnea

Completed

• Conditions: Metabolic Syndrome; Sleep Apnea

• Registration Number: NCT01610648
• Lead Sponsor: Tufts Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-05-23
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-04
• Primary Completion: 2013-05
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• Referral to the sleep center for a diagnostic study

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cut-off value determination for each of three STOP-Bang versions	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 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.

Secondary Outcome Measures

Name	Time	Method
Cut-off value determination for each of three STOP-Bang versions	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.

Trial Locations

Locations (1)

Sleep Center, Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States