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

NCT ID: NCT01976052

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-01

Study Completion Date

2017-06-01

Brief Summary

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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

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This project includes two parts:

* Genomic screening
* Biomarkers

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Obstructive sleep apnea patients

Patients with obstructive sleep apnea that has not received CPAP treatment

No interventions assigned to this group

Matched volunteers with non OSA

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

No interventions assigned to this group

Matched normal controls with normal BMI

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Malin Jonsson Fagerlund

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Malin Jonsson Fagerlund, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital and Karolinska Institutet

Locations

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

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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OSABiomarker

Identifier Type: -

Identifier Source: org_study_id

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