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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05606991




Registration number
NCT05606991
Ethics application status
Date submitted
12/07/2022
Date registered
7/11/2022

Titles & IDs
Public title
The Effect of OSA on Brain Waste Clearance
Scientific title
The Impact of 2 Weeks CPAP Withdrawal on Brain Waste Clearance in Adults With Severe Obstructive Sleep Apnoea - A Randomised Controlled Crossover Trial
Secondary ID [1] 0 0
BrainOSA-0522
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Dementia 0 0
Cognitive Impairment 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CPAP Withdrawal

No intervention: CPAP on - Participants will continue with their usual continuous positive airway pressure (CPAP) therapy as advised by their treating physician.

Experimental: CPAP off - Participants will be weaned off their usual continuous positive airway pressure (CPAP) therapy and enter a 2-week period of non-treatment.


Other interventions: CPAP Withdrawal
Complete withdrawal of continuous positive airway pressure (CPAP) therapy for a 2-week period.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in sleep-wake amplitudes (peak-trough) of blood levels of Aß
Timepoint [1] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [1] 0 0
Changes in NREM slow wave parietal cortex activity
Timepoint [1] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [2] 0 0
Changes in brain tissue oxygenation during sleep
Timepoint [2] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [3] 0 0
Changes in brain blood volume during sleep
Timepoint [3] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [4] 0 0
Changes in arterial stiffness indices during sleep
Timepoint [4] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [5] 0 0
Changes in central aortic blood pressure during sleep
Timepoint [5] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [6] 0 0
Changes in pulse wave velocity (PWV)
Timepoint [6] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [7] 0 0
Changes in sympathetic and parasympathetic activity during wake and sleep periods
Timepoint [7] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [8] 0 0
Changes in sleep-wake amplitudes (peak-trough) of blood levels of p-tau-180
Timepoint [8] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [9] 0 0
Changes in sleep-wake amplitudes (peak-trough) of blood levels of p-tau-217
Timepoint [9] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [10] 0 0
Changes in sleep-wake amplitudes (peak-trough) of blood levels of glial fibrillary acidic protein (GFAP)
Timepoint [10] 0 0
Pre- and 2 weeks post-intervention
Secondary outcome [11] 0 0
Changes in sleep-wake amplitudes (peak-trough) of blood levels of neurofilament light chain (NfL)
Timepoint [11] 0 0
Pre- and 2 weeks post-intervention

Eligibility
Key inclusion criteria
* 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.
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Commercial drivers (e.g.: drivers of heavy vehicles, public passenger vehicles, or vehicles requiring dangerous goods driver license).
* History of severe cardiovascular disease (e.g.: stroke, myocardial infarction, atrial fibrillation).
* Presence of cognitive impairment and/or established diagnosis of dementia.
* Regular use of medications which affect sleep (e.g.: benzodiazepines, opioids, stimulants, sedating antihistamines).
* 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.
* Advice against withdrawal of CPAP treatment, as determined by the participant's treating physician or study physician.
* 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.
* Current COVID-19 infection and/or experience of ongoing symptoms/sequelae following a recent COVID-19 infection.
* 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:

1. 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
2. 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
3. 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.
* Other medical conditions deemed by study physicians to warrant exclusion.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) [1] 0 0
2095 - Glebe

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keith Wong, MBBS FRACP
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05606991