NCT02293421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

November 13, 2014

Last Update Submit

December 17, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

  • Pulseoximetry

    At dignosis, one time

Study Arms (1)

STOP BANG

OTHER

STOP BANG screening questionnaire and a snore question

Other: Obstructive sleep apnea

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not able to understand the information and sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stockholm, SE-17176, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Malin Jonsson Fagerlund, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 18, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2017

Study Completion

October 1, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations