The Effect of OSA on Brain Waste Clearance
A legfontosabb adatok
- Ki végzi
- Woolcock Institute of Medical Research
- Hol
- Ausztrália1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Csak meghívásos
- Résztvevők
- 38 fő, tervezett
- Kezdés
- 2023. júl. 18.
- Tervezett befejezés
- 2026. ápr.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- CPAP Withdrawal
- A regiszteradat frissítve
- 2025. június 27.
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 apnoea who use CPAP regularly. They must be willing to stop CPAP for 14 nights.
- Életkor
- 35 to 65 years
- Nem
- All sexes
- A betegség stádiuma
- Severe obstructive sleep apnoea confirmed by a sleep study (polysomnography): AHI ≥ 30/hour, with NREM AHI ≥ 15/hour.
- Korábbi kezelés
- Must already use CPAP for OSA for > 3 months, at least 5 hours per night for > 5 nights per week.
A részvétel fő kizáró okai
- Commercial drivers, or people whose driving may be unsafe without CPAP
- History of severe heart or blood vessel disease, such as stroke, heart attack or atrial fibrillation
- Cognitive impairment or a diagnosis of dementia
- Regular use of medicines that affect sleep, shift work, or recent travel across 2 or more time zones
- Current or lasting COVID-19, past severe COVID-19 with nerve symptoms, or not up to date with COVID-19 vaccines
A regiszter feltételei, szó szerint
Mind a 17 feltétel megnézéseKevesebb
Ki vehet részt
- Community dwelling adults aged 35-65 years
- Polysomnography-confirmed severe OSA with apnea hypopnea index (AHI) ≥ 30/hour, with Non-Rapid Eye Movement (NREM) AHI ≥ 15/hour
- Established CPAP use for treatment of OSA with compliance of > 3 months, with ≥ 5 hours use per night for > 5 nights per week
- Willing to withdraw from CPAP use for 14 nights
- Able to give informed verbal and written consent
- Fluent in spoken, and comprehension of English
Ki nem vehet részt
- Regular use of medications which affect sleep (e.g.: benzodiazepines, opioids, stimulants, sedating antihistamines)
- Vulnerable to driving impairment without CPAP therapy/upon withdrawal of CPAP therapy, as assessed by: (a) positive response(s) to screening questions in the modified ASTN-Motor Vehicle Accident Questionnaire, reporting driving accidents and/or impairments prior to established CPAP therapy; AND/OR (b) the participant's treating physician
- Prior history of severe COVID-19 infection involving significant neurological symptoms (e.g.: reduced level of consciousness, delirium, encephalopathy) - warranting hospitalization
- Not up to date with the COVID-19 vaccination schedule - as per the current Australian Technical Advisory Group on Immunization (ATAGI) definition for individuals aged 16 years and over - at the time of writing this Protocol, defined as having:; Received 2 primary doses of any Therapeutic Goods Administration (TGA)-approved or TGA-recognized COVID-19 vaccine at least 14 days apart (except for the Janssen COVID-19 vaccine, where only 1 primary dose is required); PLUS; A booster dose of a TGA-approved COVID-19 vaccine (Pfizer, Moderna or AstraZeneca) at a recommended interval of 3-6 months after the receipt of 2nd primary dose; OR; For severely immunocompromised individuals: received 3 primary doses of any TGA-approved or TGA-recognized COVID-19 vaccine, with dose 3 administered within 6 months of receiving dose 2
- History of severe cardiovascular disease (e.g.: stroke, myocardial infarction, atrial fibrillation)
- Presence of cognitive impairment and/or established diagnosis of dementia
- Regular 24-hour shift workers, presence of jetlag, or history of trans-meridian travel (crossing 2 or more time zones) in the past 2 weeks
- Current COVID-19 infection and/or experience of ongoing symptoms/sequelae following a recent COVID-19 infection
- Other medical conditions deemed by study physicians to warrant exclusion
- Commercial drivers (e.g.: drivers of heavy vehicles, public passenger vehicles, or vehicles requiring dangerous goods driver license)
- Advice against withdrawal of CPAP treatment, as determined by the participant's treating physician or study physician
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 35 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
Recent ground-breaking research has shown that clearance of toxic neuro-metabolites from the brain including the proteins β-Amyloid (Aβ) and tau that form dementia causing plaques and tangles is markedly impaired when sleep is disturbed. This suggests that dementia risk may be increased in people with sleep disorders such as obstructive sleep apnea (OSA). Longitudinal studies have linked OSA with a 70-85% increased risk for mild cognitive impairment and dementia.
A teljes eredeti leírásKevesebb
Despite this strong link, little is known about the OSA-specific mechanistic underpinnings. It is not fully understood as to how sleep disturbance in OSA inhibit brain glymphatic clearance. However, it is known that OSA inhibits slow wave sleep, profoundly activates sympathetic activity, and elevates blood pressure - particularly during sleep. These disturbances have, in turn, been shown to independently inhibit glymphatic function. Previous studies have attempted to sample human cerebrospinal fluid (CSF) involved in glymphatic clearance for dementia biomarkers during sleep. However, these studies were severely limited by the need for invasive CSF sampling. To address this problem, a set of newly available, highly sensitive blood based SIMOA assays will be used to study glymphatic function in people treated for severe OSA who undergo CPAP withdrawal. Furthermore, novel methods will be utilized to capture changes in slow wave sleep, blood pressure and brain blood flow together with sleep-wake changes in blood levels of excreted neuro-metabolites to define the pathophysiological mechanisms that inhibit brain cleaning in OSA.
A vizsgálat 2 csoportja
- CPAP onNincs vizsgálati kezelés, összehasonlításként
Participants will continue with their usual continuous positive airway pressure (CPAP) therapy as advised by their treating physician.
- CPAP offA vizsgált kezelés
Participants will be weaned off their usual continuous positive airway pressure (CPAP) therapy and enter a 2-week period of non-treatment.
Kezelés: CPAP Withdrawal
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
- The Impact of 2 Weeks CPAP Withdrawal on Brain Waste Clearance in Adults With Severe Obstructive Sleep Apnoea - A Randomised Controlled Crossover Trial
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT05606991: ki vehet részt
- A regiszteradat frissítve
- 2025. június 27.