NCT01661699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

2.9 years

First QC Date

August 3, 2012

Last Update Submit

August 26, 2014

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Sleep apnea

Those suspected of sleep apnea and scheduled for polysomnography and treated with CPAP therapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those over 18 years suspected of having sleep apnea.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Cristina Reichner, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Associate Professor Medicine

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 9, 2012

Study Start

August 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

US(1)