Evaluation of the STOP-BANG Screening Questionnaire in a... | NCT02293421

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

NCT02293421

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Dec 19, 2017Actual

Enrollment

449Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Obstructive sleep apnea

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Feb 1, 2017Actual

Completion Date

Oct 1, 2017Actual

First Submitted Date

Nov 13, 2014

First Submission Date that Met QC Criteria

Nov 13, 2014

First Posted Date

Nov 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2017

Last Update Posted Date

Dec 19, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Malin Jonsson Fagerlund, MD, PhD, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Name	Class
Umeå University	OTHER
Uppsala University Hospital	OTHER
Stockholm Heart Center, Sweden	UNKNOWN
Sunderbyn Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

449Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STOP BANG	Other	STOP BANG screening questionnaire and a snore question	Other: Obstructive sleep apnea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obstructive sleep apnea	Other		STOP BANG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
STOP BANG		At diagnosis, one time
Snore question		At diagnosis, one time
Polygraphy	Apnea hypopnea index (AHI, oxygen desatuaration index (ODI)	At diganosis, one time

Secondary Outcomes

Measure	Description	Time Frame
Pulseoximetry		At dignosis, one time

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malin Jonsson Fagerlund, MD, PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital, Solna		Stockholm		SE-17176	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29958223	Derived	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.

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases