Obstructive Sleep ApneaNCT00859690
Regulation of Vascular Thrombosis in Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Weill Medical College of Cornell University.
Trial summary
Sleep Apnea is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. A better understanding of the mechanisms associated with the development of cardiovascular disease in sleep apnea is needed. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jul 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from patients presenting for sleep disorders at the Weill Cornell Pulmonary Associates / Cornell Center for Sleep Medicine practices at New York-Presbyterian Hospital in New York City.
Who may be able to join
- 21 years or older
- Patient of the Weill Cornell Pulmonary Associates and Cornell Center for Sleep Medicine practices
- Clinically indicated for an overnight sleep study within six months prior to or after the outpatient office visit
Who cannot join
- Pregnancy
About this study
Sleep Apnea is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. A better understanding of the mechanisms associated with the development of cardiovascular disease in sleep apnea is needed.
This research will investigate the function of the adenosine deaminase (ADA) in subjects with sleep disorders. This enzyme is responsible for metabolizing adenosine, a neuromodulator that is released during periods of sleep apnea and that has been found to promote vascular thrombosis. There are multiple types of ADA that are genetically determined and have different levels of function. Those different forms of this enzyme may determine groups that are more susceptible to the development of thrombosis. Given the known association between sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are differentially found in subjects with sleep apnea as compared to other sleep disturbances. The overall objective of this experiment is to assess the presence of ADA polymorphisms in sleep apnea.
Read the detailed description
Obstructive Sleep Apnea (OSA) is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. More specifically, OSA has been linked with thrombosis, or the formation of clots in the blood vessels which can lead to heart attack or stroke. A better understanding of the mechanisms associated with thrombosis and the development of cardiovascular disease in patients with obstructive sleep apnea is needed.
This research will investigate the function of the enzyme adenosine deaminase (ADA) in subjects with sleep disorders. ADA is responsible for metabolizing adenosine, a neuromodulator that is released during periods of sleep apnea and that has been found to promote vascular thrombosis. There are multiple types of ADA that are genetically determined and have different levels of function. Those different forms of this enzyme may determine groups that are more susceptible to the development of thrombosis. Given the known association between sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are differentially found in subjects with sleep apnea as compared to other sleep disturbances.
A total of 60 subjects presenting for the evaluation of sleep disorders to the Weill Cornell Pulmonary Associates and the Cornell Center for Sleep Medicine practices will be offered participation in this study. The subjects with sleep apnea will be ethnically matched to the subjects with sleep disorders other than sleep apnea (controls). Once written informed consent is obtained by the Principal Investigator, venipuncture will be performed in the office by a trained phlebotomist. A total of 15 ml (approximately 1 tablespoon) of blood will be collected. The patient will be monitored for ten minutes following the blood draw to ensure adequate hemostasis. The blood samples will be utilized for DNA sequencing and determination of adenosine deaminase genotype and phenotype.
Information from clinically indicated overnight sleep studies performed within 6 months of (prior or after) the visit will be used to categorize subjects into groups (sleep apnea vs. sleep disorder other than sleep apnea).
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Thrombosis, Adenosine Deaminase, Sleep Disorder
- Medical subject headings
- Sleep Apnea, Obstructive, Thrombosis, Sleep Wake Disorders
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 Disorder - Sleep Apnea | Subjects determined by a clinically indicated overnight sleep study (Nocturnal Polysomnography) to have Obstructive Sleep Apnea (OSA). | |
| Sleep Disorder - Not Sleep Apnea | Subjects determined by a clinically indicated overnight sleep study (Nocturnal Polysomnography) to have a sleep disorder other than Obstructive Sleep Apnea (OSA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADA gene sequence
Measured: Determined after outpatient blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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-control
- Time perspective
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Ana C Krieger, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859690
- Sponsor's protocol ID
- 0901010175
- Other IDs
- Robert Wood Johnson Foundation
- Status last verified
- Jan 2019
- First submitted
- 10 Mar 2009
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Vascular Thrombosis in Sleep Apnea
- ClinicalTrials.gov ID
- NCT00859690
- Acronym / sponsor ID
- 0901010175
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Thrombosis, Adenosine Deaminase, Sleep Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Mar 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Mar 2009 (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.
Sleep Apnea is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. A better understanding of the mechanisms associated with the development of cardiovascular disease in sleep apnea is needed.
This research will investigate the function of the adenosine deaminase (ADA) in subjects with sleep disorders. This enzyme is responsible for metabolizing adenosine, a neuromodulator that is released during periods of sleep apnea and that has been found to promote vascular thrombosis. There are multiple types of ADA that are genetically determined and have different levels of function. Those different forms of this enzyme may determine groups that are more susceptible to the development of thrombosis. Given the known association between sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are differentially found in subjects with sleep apnea as compared to other sleep disturbances. The overall objective of this experiment is to assess the presence of ADA polymorphisms in sleep apnea.
Detailed description
Obstructive Sleep Apnea (OSA) is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. More specifically, OSA has been linked with thrombosis, or the formation of clots in the blood vessels which can lead to heart attack or stroke. A better understanding of the mechanisms associated with thrombosis and the development of cardiovascular disease in patients with obstructive sleep apnea is needed.
This research will investigate the function of the enzyme adenosine deaminase (ADA) in subjects with sleep disorders. ADA is responsible for metabolizing adenosine, a neuromodulator that is released during periods of sleep apnea and that has been found to promote vascular thrombosis. There are multiple types of ADA that are genetically determined and have different levels of function. Those different forms of this enzyme may determine groups that are more susceptible to the development of thrombosis. Given the known association between sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are differentially found in subjects with sleep apnea as compared to other sleep disturbances.
A total of 60 subjects presenting for the evaluation of sleep disorders to the Weill Cornell Pulmonary Associates and the Cornell Center for Sleep Medicine practices will be offered participation in this study. The subjects with sleep apnea will be ethnically matched to the subjects with sleep disorders other than sleep apnea (controls). Once written informed consent is obtained by the Principal Investigator, venipuncture will be performed in the office by a trained phlebotomist. A total of 15 ml (approximately 1 tablespoon) of blood will be collected. The patient will be monitored for ten minutes following the blood draw to ensure adequate hemostasis. The blood samples will be utilized for DNA sequencing and determination of adenosine deaminase genotype and phenotype.
Information from clinically indicated overnight sleep studies performed within 6 months of (prior or after) the visit will be used to categorize subjects into groups (sleep apnea vs. sleep disorder other than sleep apnea).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Disorder - Sleep Apnea | – | –Subjects determined by a clinically indicated overnight sleep study (Nocturnal Polysomnography) to have Obstructive Sleep Apnea (OSA). |
| Sleep Disorder - Not Sleep Apnea | – | –Subjects determined by a clinically indicated overnight sleep study (Nocturnal Polysomnography) to have a sleep disorder other than Obstructive Sleep Apnea (OSA). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from patients presenting for sleep disorders at the Weill Cornell Pulmonary Associates / Cornell Center for Sleep Medicine practices at New York-Presbyterian Hospital in New York City.
Key inclusion criteria (3 listed)
- 21 years or older
- Patient of the Weill Cornell Pulmonary Associates and Cornell Center for Sleep Medicine practices
- Clinically indicated for an overnight sleep study within six months prior to or after the outpatient office visit
Key exclusion criteria (1 listed)
- Pregnancy
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
ADA gene sequence
Time frame: Determined after outpatient blood draw
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 18 Jan 2019.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
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Obstructive Sleep Apnea
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.
Ana C Krieger, MD, MPH principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Weill Medical College of Cornell University.
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 3 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 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
ADA gene sequence (time frame: Determined after outpatient blood draw). 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 18 Jan 2019.