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Evaluation of the STOP-BANG Screening Questionnaire in a Sleep Clinic

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Obstructive sleep apnea
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • More than 18 years old
  • First or part of the first visit to a sleep clinic
  • Planned or just conducted polysomography

Exclusion Criteria:

  • Not able to understand the information and sign informed consent

Sites / Locations

  • Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital, Solna

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

STOP BANG

Arm Description

STOP BANG screening questionnaire and a snore question

Outcomes

Primary Outcome Measures

STOP BANG
Snore question
Polygraphy
Apnea hypopnea index (AHI, oxygen desatuaration index (ODI)

Secondary Outcome Measures

Pulseoximetry

Full Information

First Posted
November 13, 2014
Last Updated
December 17, 2017
Sponsor
Karolinska University Hospital
Collaborators
Umeå University, Uppsala University Hospital, Stockholm Heart Center, Sweden, Sunderbyn Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02293421
Brief Title
Evaluation of the STOP-BANG Screening Questionnaire in a Sleep Clinic
Official Title
Evaluation of the STOP-BANG Screening Questionnaire in a Sleep Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Umeå University, Uppsala University Hospital, Stockholm Heart Center, Sweden, Sunderbyn Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Although obstructive sleep apnea (OSA) is common, most of the patients are undiagnosed. OSA is associated with a large number of co-morbidities, and thus, it is of great importance to identify the patients and start treatment in order to reduce the risks for complications. Current screening tools are quite unspecific and the golden standard methodology for diagnosis, polysomnography, is expensive and time consuming, thus not suitable for screening. In perioperative medicine the STOP BANG screening questionnaire is currently the recomended screening tool, however this questionnaire has only been evaluated in a sleep clinic in a very limited numbers of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
449 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STOP BANG
Arm Type
Other
Arm Description
STOP BANG screening questionnaire and a snore question
Intervention Type
Other
Intervention Name(s)
Obstructive sleep apnea
Primary Outcome Measure Information:
Title
STOP BANG
Time Frame
At diagnosis, one time
Title
Snore question
Time Frame
At diagnosis, one time
Title
Polygraphy
Description
Apnea hypopnea index (AHI, oxygen desatuaration index (ODI)
Time Frame
At diganosis, one time
Secondary Outcome Measure Information:
Title
Pulseoximetry
Time Frame
At dignosis, one time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: More than 18 years old First or part of the first visit to a sleep clinic Planned or just conducted polysomography Exclusion Criteria: Not able to understand the information and sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Jonsson Fagerlund, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital, Solna
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29958223
Citation
Christensson E, Franklin KA, Sahlin C, Palm A, Ulfberg J, Eriksson LI, Lindberg E, Hagel E, Jonsson Fagerlund M. Can STOP-Bang and Pulse Oximetry Detect and Exclude Obstructive Sleep Apnea? Anesth Analg. 2018 Sep;127(3):736-743. doi: 10.1213/ANE.0000000000003607.
Results Reference
derived

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Evaluation of the STOP-BANG Screening Questionnaire in a Sleep Clinic

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