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Evaluation of Potential Biomarkers for Obstructive Sleep Apnea and the Effect of Positive Pressure Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01976052
Enrollment
75
Registered
2013-11-05
Start date
2013-10-01
Completion date
2017-06-01
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Biomarkers, Genomics

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.

Detailed description

This project includes two parts: * Genomic screening * Biomarkers

Interventions

None listed

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
BiomarkerComparison between 0, 3 and 12 monthBiomarkers related to inflammation, hypoxia, oxidative stress, redox and the central nervous system will be measured

Secondary

MeasureTime frameDescription
GenomicsComparison between 0, 3, 12 monthGenomic screening by microarray
Apnea hypopnea indexComparision between 0, 3 and 12 monthApnea hypopnea index at 0, 3 and 12 month after treatment with CPAP in the obstructive sleep apnea groups
Exhaled nitric oxideComparision at 0, 3 and 12 monthMeasurement of exhaled nitric oxide

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026