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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02293421
Other study ID # OSA STOP-BANG
Secondary ID
Status Completed
Phase N/A
First received November 13, 2014
Last updated December 17, 2017
Start date November 2014
Est. completion date October 1, 2017

Study information

Verified date December 2017
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 449
Est. completion date October 1, 2017
Est. primary completion date February 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Obstructive sleep apnea


Locations

Country Name City State
Sweden Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital, Solna Stockholm

Sponsors (5)

Lead Sponsor Collaborator
Karolinska University Hospital Stockholm Heart Center, Sweden, Sunderbyn Hospital, Umeå University, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary STOP BANG At diagnosis, one time
Primary Snore question At diagnosis, one time
Primary Polygraphy Apnea hypopnea index (AHI, oxygen desatuaration index (ODI) At diganosis, one time
Secondary Pulseoximetry At dignosis, one time
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