Cerebrovascular Reactivity in Obstructive Sleep Apnea (OSA) Subjects

Spatial and Temporal Response of Cerebrovascular Response in OSA

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Recruiting
      • Toronto Gneral Hospital
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community Population

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control without Sleep Apnea
Subjects with Sleep Apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Document the diurnal differences in global CVR as measured by TCD, between those with and without OSA	Between 8pm and 7am approximately

Secondary Outcome Measures

Outcome Measure	Time Frame
Use BOLD MRI to quantify global and regional CVR in various regions and vascular territories of the brain in subjects with OSA.	one week

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Clodagh M Ryan, Toronto General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Sleep Apnea; Cerebrovascular Reactivity
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 09-0831-BE