Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT01133717

Conditions

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Sleep Apnea

Study ID

NCT01133717

Start date

Feb, 2010

Status verified date

Oct, 2010

Completion date

Apr, 2015

Anticipated

Primary completion date

Feb, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Control without Sleep Apnea

Subjects with Sleep Apnea

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Toronto Gneral Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Principal Investigator:

Clodagh Ryan, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 18, 2014

Last verified

Oct, 2010

Keywords

  • Sleep Apnea
  • Cerebrovascular Reactivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2014-12-18.