- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07913269
Heart and Brain Blood Flow in Obstructive Sleep Apnea (OSA4DFlow)
Cardiac and Cerebral Haemodynamic Changes in Obstructive Sleep Apnea Assessed With Real Time and 4D Flow MRI During Apnea, Rest and CPAP.
Obstructive sleep apnea causes repeated pauses in breathing during sleep. Breathing efforts against an occluded airway may change how blood flows through the heart and how blood drains from the brain.
This study will examine these changes in 25 adults with severe obstructive sleep apnea and 25 adults without sleep apnea, aged 18 to 65 years. Participants will attend a screening visit and one magnetic resonance imaging (MRI) visit. MRI will measure blood flow in major vessels in the chest, neck and brain at rest and during brief, standardized breathing maneuvers. Participants with sleep apnea will also be studied during obstructive apneas while sleeping in the scanner, and during continuous positive airway pressure (CPAP), which keeps the airway open.
The main objective is to quantify changes in blood flow rate and peak blood velocity before, during and at the end of obstructive apneas. The study will also compare responses to breathing maneuvers and resting blood flow between groups, and assess changes associated with CPAP in participants with sleep apnea. Secondary brain MRI outcomes are total perivascular space burden, burden in the basal ganglia and centrum semiovale, and the DTI ALPS index. BrainAGE, the difference between estimated brain age and chronological age in years, is an exploratory outcome. These MRI markers are compared between groups at baseline and after CPAP treatment.
Přehled studie
Postavení
Podmínky
Detailní popis
Background:
Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction during sleep, accompanied by continued inspiratory effort, intermittent hypoxemia, and sleep fragmentation. OSA is associated with cardiovascular and cerebrovascular disease, but the physiological mechanisms linking obstructive respiratory events to altered cerebral circulation remain incompletely understood.
During obstructive apnea, inspiratory efforts against an occluded airway generate substantial negative intrathoracic pressure. These pressure changes may affect cardiac filling, arterial blood flow, and cerebral venous drainage. In combination with changes in oxygenation, carbon dioxide, and autonomic activity, obstructive respiratory efforts may disturb the balance between cerebral arterial inflow and venous outflow, with potential consequences for intracranial pressure and cerebrospinal fluid dynamics.
Conventional assessments of OSA primarily describe respiratory event frequency and oxygen desaturation. These measurements do not directly characterize the accompanying changes in cerebral and central hemodynamics. Phase-contrast magnetic resonance imaging (MRI), including four-dimensional flow MRI and targeted two-dimensional acquisitions, enables noninvasive assessment of blood flow in the thoracic, cervical, and intracranial circulations.
Continuous positive airway pressure (CPAP) stabilizes the upper airway and reduces obstructive respiratory events. Comparing hemodynamics without and with CPAP may therefore help clarify the acute contribution of obstructive breathing to altered cerebral arterial inflow and venous drainage.
Study hypothesis:
Obstructive respiratory efforts produce transient changes in central and cerebral hemodynamics, including impaired cerebral venous drainage and altered arterial inflow. These responses differ between participants with severe OSA and controls without OSA and are attenuated during CPAP.
Furthermore, OSA severity and hemodynamic disturbances may be associated with structural and diffusion-based MRI markers related to perivascular fluid dynamics.
Objectives:
A) To characterize changes in arterial and venous blood flow during obstructive respiratory events in participants with severe OSA.
B) To compare resting cerebral and central hemodynamics between participants with severe OSA and controls without OSA.
C) To investigate arterial and venous flow responses to standardized Müller and Valsalva maneuvers and compare these responses between groups.
D) To assess the acute effects of CPAP on cerebral arterial inflow and venous outflow in participants with OSA.
E) To explore associations between OSA severity, hemodynamic measurements, and complementary structural, diffusion-based, and spectroscopic MRI measures.
Study design and examinations:
This is a prospective, single-center physiological study comprising 50 adults aged 18-65 years:
25 participants with severe OSA, defined by an apnea-hypopnea index (AHI) of at least 30 events per hour 25 controls without OSA, defined by an AHI below 5 events per hour.
Following screening, participants attend one MRI visit at Rigshospitalet, Copenhagen, Denmark. Imaging is performed using a 3-tesla MRI scanner. The examination combines structural brain imaging, diffusion imaging, magnetic resonance spectroscopy, four-dimensional flow MRI, and targeted two-dimensional phase-contrast MRI.
Flow measurements target the ascending aorta and superior vena cava in the thorax; the bilateral internal carotid arteries, vertebral arteries, and internal jugular veins in the neck; and the superior sagittal sinus intracranially. Total cerebral blood flow is calculated as the sum of flow through the bilateral internal carotid and vertebral arteries.
In the OSA group, additional measurements are obtained during sleep to capture spontaneous obstructive respiratory events. Selected acquisitions are repeated during CPAP to allow within-participant comparisons. Physiological monitoring is used to relate MRI measurements to respiratory effort, oxygen desaturation, and recovery following respiratory events.
Endpoints:
Primary endpoint:
Changes in volumetric blood flow rate, Q(t), and peak velocity across the phases of obstructive respiratory events in the ascending aorta, superior vena cava, internal carotid arteries, vertebral arteries, internal jugular veins, and superior sagittal sinus. Event-related analyses will distinguish obstructive effort, desaturation, and arousal or recovery phases where supported by the physiological recordings.
Secondary endpoints:
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Hemodynamic responses to respiratory maneuvers:
Changes in volumetric blood flow rate and peak velocity during Müller and Valsalva maneuvers, including comparisons between the OSA and control groups.
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Resting total cerebral blood flow:
Total cerebral blood flow measured using four-dimensional flow MRI, including comparisons between groups and within-participant changes during CPAP in the OSA group.
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Resting arterial and venous flow:
Mean flow in the intracranial, cervical, and thoracic vessels examined, including comparisons between groups and within-participant changes during CPAP in the OSA group.
Additional exploratory assessments:
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Enlarged perivascular spaces:
Structural MRI will be used to characterize enlarged perivascular spaces, including overall burden and regional measures in the basal ganglia and centrum semiovale.
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Perivascular water diffusion:
Diffusion imaging will be used to calculate the diffusion tensor imaging analysis along the perivascular space (DTI-ALPS) index, an indirect research marker of directional water diffusion in periventricular regions.
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Cerebral lactate:
Magnetic resonance spectroscopy will be used to explore cerebral lactate signals at baseline and during apnea-related acquisitions.
4 BrainAGE T1-weighted structural MRI will be used to estimate brain age and calculate the difference between predicted brain age and chronological age (BrainAGE), an exploratory imaging marker of structural brain ageing.
5. Associations with OSA severity: Hemodynamic and complementary MRI measures will be explored in relation to respiratory event frequency and measures of nocturnal oxygen desaturation.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Casper S Riedel, MD, PhD
- Telefonní číslo: +4535452023
- E-mail: casper.schwartz.riedel@regionh.dk
Studijní místa
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Copenhagen, Dánsko, 2100
- Department of Diagnostic Radiology
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Kontakt:
- Adam E Hansen, MD, PhD
- E-mail: adam.espe.hansen@regionh.dk
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Glostrup Municipality, Dánsko, 2600
- Danish Center for Sleep Medicine
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Kontakt:
- Poul J Jennum, MD, PhD
- E-mail: poul.joergen.jennum@regionh.dk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The study population comprises adults aged 18-65 years referred to the Danish Center for Sleep Medicine, Rigshospitalet, Denmark, for evaluation of suspected obstructive sleep apnea (OSA). Fifty participants will be enrolled: 25 with severe OSA, defined by a diagnostic apnea-hypopnea index (AHI) ≥30 events/hour, and 25 controls without OSA, defined by a diagnostic AHI <5 events/hour. Participants will be selected according to the protocol-defined eligibility criteria and must be able to provide informed consent.
Popis
Inclusion Criteria:
Both groups
- Age 18 to 65 years.
- Able to provide informed consent
OSA group • Severe OSA confirmed by a diagnostic sleep examination, with AHI at least 30 events per hour.
Control group
• Referred for assessment of suspected OSA, with a diagnostic AHI below 5 events per hour.
Exclusion Criteria:
- Contraindication to MRI, including a pacemaker that is not MRI compatible, ferromagnetic implants, first trimester pregnancy, or severe claustrophobia.
- Significant cardiac disease, including left ventricular ejection fraction below 40%, myocardial infarction within the previous 3 months, or untreated arrhythmia; atrial fibrillation; or pulmonary hypertension that may affect flow measurements.
- Previous stroke, intracerebral haemorrhage or intracranial surgery, severe depression, or psychosis.
- An unstable or seriously progressive medical condition, as assessed by a physician.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_CONTROL
- Časové perspektivy: OTHER
Kohorty a intervence
Skupina / kohorta |
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Severe obstructive sleep apnea
Adults aged 18 to 65 years with AHI at least 30 events per hour. Participants undergo MRI at rest and during the Mueller and Valsalva maneuvers, real time flow measurements during spontaneous obstructive apneas, and 4D flow MRI during CPAP. |
|
Controls
Adults aged 18 to 65 years referred for assessment of suspected OSA, with AHI below 5 events per hour. Participants undergo MRI at rest and during the Mueller and Valsalva maneuvers. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in volumetric blood flow rate during spontaneous obstructive apneas
Časové okno: At baseline and after 6 months CPAP treatment
|
Percentage change in volumetric blood flow rate Q(t), measured with real time 2D phase contrast MRI in the ascending aorta, superior vena cava, bilateral internal carotid arteries, bilateral vertebral arteries, bilateral internal jugular veins and superior sagittal sinus. Each vessel is assessed separately by comparing the baseline immediately before an event with phases of obstructive effort, desaturation and apnea termination. The analysis is restricted to participants with OSA. At least three usable obstructive apneas per location or measurement plane are targeted. |
At baseline and after 6 months CPAP treatment
|
|
Change in peak blood velocity during spontaneous obstructive apneas
Časové okno: At baseline and after 6 months CPAP treatment
|
Percentage change in peak blood velocity, measured with real time 2D phase contrast MRI in the ascending aorta, superior vena cava, bilateral internal carotid arteries, bilateral vertebral arteries, bilateral internal jugular veins and superior sagittal sinus. Each vessel is assessed separately by comparing the baseline immediately before an event with phases of obstructive effort, desaturation and apnea termination. Underlying velocity measurements are expressed in cm/s. The analysis is restricted to participants with OSA. |
At baseline and after 6 months CPAP treatment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Blood flow rate response to Mueller and Valsalva maneuvers
Časové okno: At baseline
|
Change in volumetric blood flow rate from the local baseline during Mueller and Valsalva maneuvers, reported separately for each maneuver and vessel. Real time 2D phase contrast MRI measures the ascending aorta, superior vena cava, bilateral internal carotid, vertebral and internal jugular vessels, and superior sagittal sinus. Responses are compared between OSA and control participants. |
At baseline
|
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Peak blood velocity response to Mueller and Valsalva maneuvers
Časové okno: At baseline
|
Change in peak blood velocity from the local baseline during Mueller and Valsalva maneuvers, reported separately for each maneuver and vessel. Underlying velocity measurements are expressed in cm/s. Responses in the target chest, neck and intracranial vessels are compared between OSA and control participants. |
At baseline
|
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Total cerebral blood flow (TCBF)
Časové okno: At baseline and after 6 months CPAP treatment
|
Total cerebral blood flow in mL/min, calculated as the sum of bilateral internal carotid and vertebral artery flow using 4D flow MRI. Resting values without CPAP are compared between OSA and control participants. Within the OSA group, changes from without CPAP to during CPAP are assessed, with control values providing a reference. |
At baseline and after 6 months CPAP treatment
|
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Arterial and venous blood flow
Časové okno: At baseline and after 6 months CPAP treatment
|
Mean arterial and venous volumetric flow rate in mL/min, measured using 4D flow MRI at the intracranial, neck and thoracic levels. Each vessel is assessed separately. Resting values without CPAP are compared between OSA and control participants. Within the OSA group, changes from without CPAP to during CPAP are assessed. |
At baseline and after 6 months CPAP treatment
|
|
Perivascular space burden
Časové okno: At baseline and after 6 months CPAP treatment
|
Perivascular space burden assessed on structural MRI and compared between OSA and control participants. Total burden and regional burden in the basal ganglia and centrum semiovale are reported separately, using prespecified definitions and the same rating or quantification method in both groups. |
At baseline and after 6 months CPAP treatment
|
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DTI-ALPS index
Časové okno: At baseline and after 6 months CPAP treatment
|
Dimensionless diffusion tensor imaging analysis along the perivascular space index, calculated separately in each hemisphere. The mean of the left and right indices is compared between OSA and controls; side specific values are supplementary. |
At baseline and after 6 months CPAP treatment
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cerebral lactate during rest and the sleep recording block
Časové okno: At baseline and after 6 months CPAP treatment
|
Cerebral lactate measured with proton magnetic resonance spectroscopy during a resting acquisition and sleep. A corresponding water reference is acquired. Apneas and participant state during the block are annotated. The sleep spectrum is a block measurement unless separate event specific spectra are technically available and validated. |
At baseline and after 6 months CPAP treatment
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- OSA-4DFlow
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