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

Metabolic Syndrome Clinical Trial

Official title:

Improving the Sensitivity and Specificity of the STOP-Bang Screening Questionnaire for Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610648
• Other study ID #: IRB#10391
• Status: Completed
• Phase: N/A
• First received: May 23, 2012
• Last updated: April 20, 2016
• Start date: June 2012
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: January 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Referral to the sleep center for a diagnostic study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Metabolic Syndrome
• Metabolic Syndrome X
• Sleep Apnea
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
United States	Sleep Center, Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cut-off value determination for each of three STOP-Bang versions	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)	No
Secondary	Cut-off value determination for each of three STOP-Bang versions	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)	No