NCT00859690

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

4.3 years

First QC Date

March 10, 2009

Last Update Submit

January 17, 2019

Conditions

Keywords

Obstructive Sleep ApneaThrombosisAdenosine DeaminaseSleep Disorder

Outcome Measures

Primary Outcomes (1)

  • ADA gene sequence

    Determined after outpatient blood draw

Study Arms (2)

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).

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

A total of 15ml (approximately 1 tablespoon) of whole blood will be collected from each subject during his or her out-patient office visit. This sample will be retained for genomic analysis

MeSH Terms

Conditions

Sleep Apnea, ObstructiveThrombosisSleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasNervous System DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Ana C Krieger, MD, MPH

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 18, 2019

Record last verified: 2019-01