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Heart and Brain Blood Flow in Obstructive Sleep Apnea (OSA4DFlow)

28 ottobre 2026 aggiornato da: Casper Schwartz Riedel, Copenhagen University Hospital, Rigshospitalet

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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:

  1. 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.

  2. 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.

  3. 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:

  1. 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.

  2. 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.

  3. 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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

50

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: CASE_CONTROL
  • Prospettive temporali: OTHER

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in volumetric blood flow rate during spontaneous obstructive apneas
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Blood flow rate response to Mueller and Valsalva maneuvers
Lasso di tempo: 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
Peak blood velocity response to Mueller and Valsalva maneuvers
Lasso di tempo: 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
Total cerebral blood flow (TCBF)
Lasso di tempo: 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
Arterial and venous blood flow
Lasso di tempo: 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
Lasso di tempo: 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
DTI-ALPS index
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Cerebral lactate during rest and the sleep recording block
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 novembre 2026

Completamento primario (Stimato)

15 maggio 2028

Completamento dello studio (Stimato)

15 novembre 2028

Date di iscrizione allo studio

Primo inviato

28 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2026

Primo Inserito (Effettivo)

3 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • OSA-4DFlow

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .