Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Sponsor Karolinska University Hospital
Start date October 2013
End date June 2017
Trial size 75 participants
Trial identifier NCT01976052, OSABiomarker

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients with obstructive sleep apnea that has not received CPAP treatment
Matched volunteers without OSA. Matched in respect to age and BMI
Volunteers that are matched according to age but has a normal BMI

Primary Outcomes

Measure
Biomarker
time frame: Comparison between 0, 3 and 12 month

Secondary Outcomes

Measure
Genomics
time frame: Comparison between 0, 3, 12 month
Apnea hypopnea index
time frame: Comparision between 0, 3 and 12 month
Exhaled nitric oxide
time frame: Comparision at 0, 3 and 12 month

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

OSA-patients with moderate and severe OSA (n=15+15) 1. Adult, 18-75 years of age 2. Moderate (AHI 15-30) or Severe (AHI >30) OSA that are currently untreated and planned for CPAP-treatment 3. Otherwise healthy except for well controlled hypertension since 3 month, Max BP 140/90 4. Non-smokers 5. Not pregnant 6. No medications with antioxidants 7. BMI of <40 Controls (AHI<5) Two groups of controls 1. Matched controls The same age, sex and BMI ± 3 and eventual hypertension. These controls should also fulfill criteria 4-6 above. 2. Healthy controls with normal BMI (19-25) These controls should also fulfill criteria 1., 4-6 above. Exclusion Criteria: - If they no not fulfil the inclusion criteria

Additional Information

Principal investigator Malin Jonsson Fagerlund, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.