Study to Assess the Changes in Blood Clotting Factors and Blood Vessel Wall Function in Obstructive Sleep Apnea

NCT00936481 | Completed Results

• 1 other identifier: 090265
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea is a condition in which people have decreased breathing during their sleep. Untreated sleep apnea has been linked to increased risk for cardiovascular diseases. This research study is looking at blood clotting factors and blood vessel function in health volunteers and patients with newly diagnosed or untreated obstructive sleep apnea to better understand the underlying mechanisms for increased cardiovascular risk.

Conditions

Obstructive Sleep Apnea

Keywords

OSA

Outcome Measures

Primary Outcomes (1)

• Comparison of Levels of Mean PAI-1 Activity in Patients With Obstructive Sleep Apnea and Controls.

  at the initial visit

Secondary Outcomes (1)

• Comparison of Endothelial (Blood Vessel) Wall Diameter in Patients With Obstructive Sleep Apnea Versus Controls.

  at initial visit

Study Arms (2)

Healthy controls

18 years or older with body mass index between 25-45

Obstructive Sleep Apnea Group

Age 18 years or older with body mass index between 25 and 45

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We are looking for adults over age 18 years without significnt medical or psychiatric conditions (other than sleep apnea).

You may qualify if:

• Age 18 years or older.
• Subjects are able and willing to provide informed consent.
• Subjects are willing to cooperate with polysomnography and have serial blood draws over a 24-hour period.
• Evidence for OSA (AHI\>5 events/hour) without treatment or suspected OSA based on symptoms in the patient group.
• Body mass index of 25-45

You may not qualify if:

• History of myocardial infarction, stroke or transient ischemic attack (TIA) or peripheral vascular disease.
• History of chronic diseases such as diabetes mellitus, uncontrolled hypertension (SBP \>160, DBP \> 120), renal failure on dialysis, cancer, autoimmune or liver disease.
• A significant history of medical or psychiatric disease that may impair participation in the trial.
• Evidence of medical instability (cardiac arrhythmias, congestive heart failure, pulmonary disease) that require an expedited evaluation and treatment of the OSA.
• History of alcohol, or drug abuse during the one-year-period prior to trial participation.
• Current use of tobacco products.
• Current treatment with angiotensin converting enzyme-inhibitors and or chronic use of non-steroidal anti-inflammatory agents.
• Another primary sleep disorder that requires intervention with medications or cause disrupted sleep.
• Patients with unusual sleep or wake habits, including shift work.
• Transmeridian travel in the previous 3 months.
• Patients with OSA who have already received treatment with CPAP, surgery or oral appliance.
• Pregnancy; as hormonal changes affect sleep disordered breathing.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center,Department of Neurology

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.

  PMID: 16282178 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples to measure plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA)levels, endothelial function,fasting lipid profile and glucose levels.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Kanika Bagai, MD, Assistant Professor
• Organization: Vanderbilt Universit

kanika.bagai@vanderbilt.edu

6153220283

Study Officials

• Kanika Bagai, M.D

  Vanderbilt University Medical Center, Nashville, TN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: February 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 25, 2013
• Results First Posted: October 25, 2013

Record last verified: 2013-08

Locations

US (1)