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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976052
• Other study ID #: OSABiomarker
• Status: Completed
• Start date: October 1, 2013
• Est. completion date: June 1, 2017

Study information

• Verified date: October 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This project includes two parts:

• Genomic screening

• Biomarkers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Sweden	Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital, Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker	Biomarkers related to inflammation, hypoxia, oxidative stress, redox and the central nervous system will be measured	Comparison between 0, 3 and 12 month
Secondary	Genomics	Genomic screening by microarray	Comparison between 0, 3, 12 month
Secondary	Apnea hypopnea index	Apnea hypopnea index at 0, 3 and 12 month after treatment with CPAP in the obstructive sleep apnea groups	Comparision between 0, 3 and 12 month
Secondary	Exhaled nitric oxide	Measurement of exhaled nitric oxide	Comparision at 0, 3 and 12 month