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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Sleep Apnea

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 Type: Observational
• Enrollment (Actual): 258

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Sleep Center, Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting for a sleep study to Tufts Medical Center

Description

Inclusion Criteria:

• Referral to the sleep center for a diagnostic study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients presenting for a diagnostic sleep study; Patients presenting to the TMC sleep center for sleep study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Investigators: Principal Investigator: Roman Schumann, MD, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 23, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (Estimate): June 4, 2012

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: OSA; metabolic syndrome; Oxygen desaturation index; Apnea-hypopnea index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Insulin Resistance; Hyperinsulinism; Sleep Apnea Syndromes; Apnea; Metabolic Syndrome
• Other Study ID Numbers: IRB#10391