Heart and Brain Blood Flow in Obstructive Sleep Apnea
A legfontosabb adatok
- Ki végzi
- Copenhagen University Hospital, Rigshospitalet
- Hol
- Dánia2 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 50 fő, tervezett
- Kezdés
- 2026. nov. 15.
- Várható befejezés
- 2028. nov. 15.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A regiszteradat frissítve
- 2026. november 3.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with severe obstructive sleep apnea, where breathing stops again and again during sleep. It is also looking for adults checked for sleep apnea who turned out not to have it, as a comparison group.
- Életkor
- 18 to 65 years
- Nem
- All sexes
- A betegség stádiuma
- Sleep apnea group: severe obstructive sleep apnea confirmed by a sleep test, with AHI (breathing pauses per hour) of at least 30 events per hour. Comparison group: sent for a sleep apnea check, with AHI below 5 events per hour.
- Biomarker vagy leletérték
- AHI at least 30 events per hour (sleep apnea group) or below 5 events per hour (comparison group) on a diagnostic sleep test.
A részvétel fő kizáró okai
- Cannot have an MRI scan, for example a pacemaker that is not MRI safe, metal implants, first trimester pregnancy or severe fear of closed spaces
- Serious heart disease, such as heart pumping strength (ejection fraction) below 40%, heart attack in the last 3 months, or untreated irregular heartbeat
- Atrial fibrillation or high blood pressure in the lungs (pulmonary hypertension)
- Past stroke, brain bleeding or brain surgery, severe depression or psychosis
- An unstable or quickly worsening medical condition, as judged by a doctor
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 65 év között vagy?
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- 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.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Cardiac and Cerebral Haemodynamic Changes in Obstructive Sleep Apnea Assessed With Real Time and 4D Flow MRI During Apnea, Rest and CPAP.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT07913269: ki vehet részt
- A regiszteradat frissítve
- 2026. november 3.