Oxidative Stress in Obstructive Sleep Apnea: Correlation... | NCT01661699

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

NCT01661699

Sponsor

Georgetown University

Status

Completed

Last Update Posted

Aug 28, 2014Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Sleep Apnea, Obstructive

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Aug 3, 2012

First Submission Date that Met QC Criteria

Aug 6, 2012

First Posted Date

Aug 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2014

Last Update Posted Date

Aug 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christina Reichner, M.D., M.D., Associate Professor Medicine, Georgetown UniversityPrincipal Investigator

Lead Sponsor

Georgetown UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep apnea		Those suspected of sleep apnea and scheduled for polysomnography and treated with CPAP therapy.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Those over 18 years suspected of having sleep apnea.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cristina Reichner, MD	Georgetown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University Hospital		Washington D.C.	District of Columbia	20007	United States

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided