Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance

Sleep Apnea, Obstructive Clinical Trial

Official title:

Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661699
• Other study ID #: 2011-416
• Status: Completed
• Phase: N/A
• First received: August 3, 2012
• Last updated: August 26, 2014
• Start date: August 2011
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to check blood and urine levels to further define markers/tests in the blood and urine that would be useful in following patients with obstructive sleep apnea and then to see if by wearing CPAP every night, these markers can be reduced. This research is being done because currently there are no effective blood or urine markers to determine how well CPAP is working.

Description:

The goal of this study is to further define biomarkers that would be useful in following patients with obstructive sleep apnea and examining their response to compliance to therapy with CPAP. To date no correlation between biomarkers of oxidative stress and compliance to CPAP has been measured. CPAP is the most effective treatment for obstructive sleep apnea and has been show to reduce blood pressure and decrease oxidative stress.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and Women over 18 years suspected of having sleep apnea

Exclusion Criteria:

• Those under 18 years or not suspected of having sleep apnea

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining biomarkers for polysomnography characteristics before and after CPAP treatment	The primary objective of this pilot study will determine the biomarkers for polysomnography characteristics with CPAP treatment from baseline to 6 months in patients with obstructive sleep apnea. The results will guide biomarker selection for full scale studies.	6 months	No