Sleep Apnea, ObstructiveNCT01661699
Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance
An observational study of Sleep Apnea, Obstructive, run by Georgetown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those over 18 years suspected of having sleep apnea.
Who may be able to join
- Men and Women over 18 years suspected of having sleep apnea
Who cannot join
- Those under 18 years or not suspected of having sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea | Those suspected of sleep apnea and scheduled for polysomnography and treated with CPAP therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Reichner, M.D., Georgetown University
- Investigators
- Cristina Reichner, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661699
- Sponsor's protocol ID
- 2011-416
- Status last verified
- Aug 2014
- First submitted
- 3 Aug 2012
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance
- ClinicalTrials.gov ID
- NCT01661699
- Acronym / sponsor ID
- 2011-416
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea | – | –Those suspected of sleep apnea and scheduled for polysomnography and treated with CPAP therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those over 18 years suspected of having sleep apnea.
Key inclusion criteria (1 listed)
- Men and Women over 18 years suspected of having sleep apnea
Key exclusion criteria (1 listed)
- Those under 18 years or not suspected of having sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining biomarkers for polysomnography characteristics before and after CPAP treatment
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Reichner, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining biomarkers for polysomnography characteristics before and after CPAP treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2014.