Clinical trial NCT01610648: Improving the STOP-Bang Screening Questionnaire for Patients With Sleep Apnea
Official title: Improving the Sensitivity and Specificity of the STOP-Bang Screening Questionnaire for Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Metabolic Syndrome
Keywords: OSA
metabolic syndrome
Apnea-hypopnea index
Oxygen desaturation index
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting for a sleep study to 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.

Eligibility criteria: Inclusion Criteria:

* Referral to the sleep center for a diagnostic study

Primary outcomes:
measure: Cut-off value determination for each of three STOP-Bang versions
timeFrame: The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
Secondary outcomes:
measure: Cut-off value determination for each of three STOP-Bang versions
timeFrame: The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Sleep Center, Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Roman Schumann, MD
role: PRINCIPAL_INVESTIGATOR
References: