- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01133717
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- Rekruttering
- Toronto Gneral Hospital
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Hovedetterforsker:
- Clodagh Ryan, MD
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Underetterforsker:
- J Fisher, MD
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Underetterforsker:
- J Duffin, PhD
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Underetterforsker:
- D Mikulis, MD
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Underetterforsker:
- a Battisti, BSc
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Underetterforsker:
- O Pucci, BSc
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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Control without Sleep Apnea
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Subjects with Sleep Apnea
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Document the diurnal differences in global CVR as measured by TCD, between those with and without OSA
Tidsramme: Between 8pm and 7am approximately
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Between 8pm and 7am approximately
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Use BOLD MRI to quantify global and regional CVR in various regions and vascular territories of the brain in subjects with OSA.
Tidsramme: one week
|
one week
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Clodagh M Ryan, Toronto General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09-0831-BE
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