Cerebrovascular Reactivity in Obstructive Sleep Apnea (OSA) Subjects
Recruitment status was Recruiting
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Purpose
Obstructive sleep apnea (OSA) is a prevalent sleep breathing disorder in the general population in which recurrent collapse of the upper airway occurs during sleep. OSA is more prevalent in subjects with stroke and is associated with a 3 fold increased risk of stroke. This makes it a serious public health problem. Approximately 50% of subjects with OSA are asymptomatic and are often only detected following investigation for the cause of heart disease or a stroke. In subjects who are treated for OSA many are intolerant or poorly compliant with treatment. Therefore, the identification of those subjects with OSA most at risk of adverse consequences such as stroke is important, so that treatment compliance can be improved.
Therfore, the investigators want to determine if compared to subjects without OSA, subjects with OSA have evidence of increased stroke risk by assessment of changes in cerebral blood flow (cerebrovascular reactivity) as measured on Doppler ultrasound of the middle cerebral artery (TCD) and blood oxygen level-dependent magnetic resonance imaging of patterns of cerebral blood flow (BOLD MRI) to two stimuli. These stimuli include increased carbon dioxide concentrations (causes increased cerebral blood flow) and reduced oxygen concentrations (causing decreased cerebral blood flow). In order to deliver these stimuli the investigators will use a special machine (RespiractTM) which allows for the precise control of carbon dioxide and oxygen concentrations in the lungs and blood. The precise control of carbon dioxide and oxygen in conjunction with BOLD MRI has enabled the production of detailed maps of the brain that identify areas of healthy and abnormal blood supply.
| Condition |
|---|
|
Sleep Apnea |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Spatial and Temporal Response of Cerebrovascular Response in OSA |
- Document the diurnal differences in global CVR as measured by TCD, between those with and without OSA [ Time Frame: Between 8pm and 7am approximately ] [ Designated as safety issue: No ]
- Use BOLD MRI to quantify global and regional CVR in various regions and vascular territories of the brain in subjects with OSA. [ Time Frame: one week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Control without Sleep Apnea |
| Subjects with Sleep Apnea |
Detailed Description:
OSA is associated with increased risk of cardiovascular and cerebrovascular disease compared to the general population. The mechanism for the increased stroke risk in OSA is unknown. However, the constellation of adverse pathophysiological consequences, including intermittent hypoxia and carbon-dioxide retention as a result of OSA may be detrimental to CVR and predispose the brain to ischemia. Previous studies in OSA subjects have measured CVR only using TCD. Therefore, our study will examine CVR by two methods (TCD and BOLD-MRI) with reliable and reproducible hypercapnia and independent control of oxygen saturation (RespiractTM). Patterns seen on CVR may eventually allow the identification of OSA patients who will be at greatest risk for stroke and will therefore, require aggressive risk reduction and/or treatment irrespective of symptoms.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Community Population
Inclusion Criteria:
- Subjects referred for sleep studies
Exclusion Criteria:
- Known cardiac, neurological or major liver or kidney disease -
- Cardioverter/defibrillator metal heart valve or pacemaker
- Vascular stent implanted within 6 weeks
- Severe claustrophobia
- Pregnancy
- Shrapnel or history of ophthalmic foreign body
- Resting oxygen saturation on room air < 95%
- Insulin-dependent diabetes
- Obstructive or restrictive lung disease such that subject is unable to walk up 2 flights of stairs
- Major depression.
Contacts and Locations| Contact: Clodagh M Ryan, MD | 4163404719 | clodagh.ryan@uhn.on.ca |
| Contact: Ann battisti, BSc | abattist@uhnres.utoronto.ca |
| Canada, Ontario | |
| Toronto Gneral Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Principal Investigator: Clodagh Ryan, MD | |
| Sub-Investigator: J Fisher, MD | |
| Sub-Investigator: J Duffin, PhD | |
| Sub-Investigator: D Mikulis, MD | |
| Sub-Investigator: a Battisti, BSc | |
| Sub-Investigator: O Pucci, BSc | |
| Principal Investigator: | Clodagh M Ryan | Toronto General Hospital |
More Information
No publications provided
| Responsible Party: | Clodagh Ryan, University Health Network |
| ClinicalTrials.gov Identifier: | NCT01133717 History of Changes |
| Other Study ID Numbers: | 09-0831-BE |
| Study First Received: | May 20, 2010 |
| Last Updated: | October 20, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Sleep Apnea Cerebrovascular Reactivity |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013