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

NCT01610648 | Completed

• 1 other identifier: IRB#10391
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Metabolic Syndrome

Keywords

OSA; metabolic syndrome; Apnea-hypopnea index; Oxygen desaturation index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Patients presenting for a diagnostic sleep study

Patients presenting to the TMC sleep center for sleep study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting for a sleep study to Tufts Medical Center

You may qualify if:

• Referral to the sleep center for a diagnostic study

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Sleep Center, Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Roman Schumann, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: June 4, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: January 1, 2016
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

US (1)