NCT01976052

Brief Summary

Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by polygraphy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

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

October 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3.7 years

First QC Date

October 21, 2013

Last Update Submit

October 13, 2020

Conditions

Obstructive Sleep Apnea

Keywords

BiomarkersGenomics

Outcome Measures

Primary Outcomes (1)

  • Biomarker

    Biomarkers related to inflammation, hypoxia, oxidative stress, redox and the central nervous system will be measured

    Comparison between 0, 3 and 12 month

Secondary Outcomes (3)

  • Genomics

    Comparison between 0, 3, 12 month

  • Apnea hypopnea index

    Comparision between 0, 3 and 12 month

  • Exhaled nitric oxide

    Comparision at 0, 3 and 12 month

Study Arms (3)

Obstructive sleep apnea patients

Patients with obstructive sleep apnea that has not received CPAP treatment

Matched volunteers with non OSA

Matched volunteers without OSA. Matched in respect to age and BMI

Matched normal controls with normal BMI

Volunteers that are matched according to age but has a normal BMI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

OSA patients will be recruited from an outpatient sleep clinic

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

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma

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 University Hospital and Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 21, 2013

First Posted

November 5, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

SE(1)