- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2N2
- Recrutement
- Toronto Gneral Hospital
-
Chercheur principal:
- Clodagh Ryan, MD
-
Sous-enquêteur:
- J Fisher, MD
-
Sous-enquêteur:
- J Duffin, PhD
-
Sous-enquêteur:
- D Mikulis, MD
-
Sous-enquêteur:
- a Battisti, BSc
-
Sous-enquêteur:
- O Pucci, BSc
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
---|
Control without Sleep Apnea
|
Subjects with Sleep Apnea
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Document the diurnal differences in global CVR as measured by TCD, between those with and without OSA
Délai: Between 8pm and 7am approximately
|
Between 8pm and 7am approximately
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Use BOLD MRI to quantify global and regional CVR in various regions and vascular territories of the brain in subjects with OSA.
Délai: one week
|
one week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Clodagh M Ryan, Toronto General Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 09-0831-BE
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .