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

NCT ID: NCT01610648

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Sleep Apnea Metabolic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients presenting for a diagnostic sleep study

Patients presenting to the TMC sleep center for sleep study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Referral to the sleep center for a diagnostic study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roman Schumann, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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Sleep Center, Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#10391

Identifier Type: -

Identifier Source: org_study_id

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