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

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ClinicalTrials.gov Identifier: NCT01976052
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Malin Jonsson Fagerlund, Karolinska University Hospital

Study Description
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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.

Condition or disease
Obstructive Sleep Apnea

Detailed Description:

This project includes two parts:

  • Genomic screening
  • Biomarkers
Study Design
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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
OSA patients will be recruited from an outpatient sleep clinic
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976052


Locations
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Sweden
Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital, Solna
Stockholm, Sweden, SE-17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Malin Jonsson Fagerlund, MD, PhD Karolinska University Hospital and Karolinska Institutet
More Information
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Responsible Party: Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01976052    
Other Study ID Numbers: OSABiomarker
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Keywords provided by Malin Jonsson Fagerlund, Karolinska University Hospital:
Biomarkers
Genomics
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases