Heart and Brain Blood Flow in Obstructive Sleep Apnea
Key facts
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Where
- Copenhagen and Glostrup Municipality, DenmarkSee the 2 sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 50 people, planned
- Starts
- 15 Nov 2026
- Expected to end
- 15 Nov 2028
- Type of study
- Observational, 2 groups
- Record updated
- 3 November 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Contraindication to MRI, including a pacemaker that is not MRI compatible, ferromagnetic implants, first trimester pregnancy, or severe claustrophobia
- Previous stroke, intracerebral haemorrhage or intracranial surgery, severe depression, or psychosis
- An unstable or seriously progressive medical condition, as assessed by a physician
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Denmark
- Department of Diagnostic RadiologyCopenhagen, DenmarkContact: Adam E Hansen, MD, PhDNo longer taking part
- Danish Center for Sleep MedicineGlostrup Municipality, DenmarkContact: Poul J Jennum, MD, PhDNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cardiac and Cerebral Haemodynamic Changes in Obstructive Sleep Apnea Assessed With Real Time and 4D Flow MRI During Apnea, Rest and CPAP.
- Fit questions
- Built from NCT07913269, who can take part
- Record updated
- 3 November 2026