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Completed

NCT Number: NCT01976052

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Stockholm, SE-17176, Sweden

About this study

This project includes two parts:

  • Genomic screening
  • Biomarkers

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

OSA-patients with moderate and severe OSA (n=15+15)

  • Adult, 18-75 years of age
  • Moderate (AHI 15-30) or Severe (AHI >30) OSA that are currently untreated and planned for CPAP-treatment
  • Otherwise healthy except for well controlled hypertension since 3 month, Max BP 140/90
  • Non-smokers
  • Not pregnant
  • No medications with antioxidants
  • BMI of <40

Controls (AHI<5) Two groups of controls

  • Matched controls The same age, sex and BMI ± 3 and eventual hypertension. These controls should also fulfill criteria 4-6 above.
  • 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

Treatment and study plan

Primary outcomes

  1. Biomarker

    Time frame: Comparison between 0, 3 and 12 month

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

Secondary outcomes

  1. Genomics

    Time frame: Comparison between 0, 3, 12 month

    Genomic screening by microarray

  2. Apnea hypopnea index

    Time frame: Comparision between 0, 3 and 12 month

    Apnea hypopnea index at 0, 3 and 12 month after treatment with CPAP in the obstructive sleep apnea groups

  3. Exhaled nitric oxide

    Time frame: Comparision at 0, 3 and 12 month

    Measurement of exhaled nitric oxide

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2013
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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