The Effect of OSA on Brain Waste Clearance
Key facts
- Who runs it
- Woolcock Institute of Medical Research
- Where
- Macquarie Park, AustraliaSee the site
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 38 people, planned
- Started
- 18 Jul 2023
- Planned end
- Apr 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- CPAP Withdrawal
- Record updated
- 27 June 2025
Who can take part
- Age
- 35 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
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 35 and 65 years old?
Where in Australia
- Woolcock Institute of Medical ResearchMacquarie Park, AustraliaNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- CPAP onNo study treatment, for comparison
Participants will continue with their usual continuous positive airway pressure (CPAP) therapy as advised by their treating physician.
- CPAP offTreatment being tested
Participants will be weaned off their usual continuous positive airway pressure (CPAP) therapy and enter a 2-week period of non-treatment.
Treatment: CPAP Withdrawal
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
- The Impact of 2 Weeks CPAP Withdrawal on Brain Waste Clearance in Adults With Severe Obstructive Sleep Apnoea - A Randomised Controlled Crossover Trial
- Fit questions
- Built from NCT05606991, who can take part
- Record updated
- 27 June 2025