None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA), a sleep disorder that results in hypersomnia and sleep fragmentation, is identified as a possible risk factor for cognitive decline in the elderly. Although the occurrence of OSA in certain neurodegenerative disorders, particularly Alzheimer’s disease (AD), has been examined, its role and impact in patients with mild cognitive impairment (MCI) - a group 'at risk' of dementia progression - is yet to be established. Continuous positive airway pressure (CPAP) treatment has been shown to decrease sleep disturbance in patients with AD and OSA over periods of up to three weeks, and positive effects on global cognition, executive functioning and psychomotor speed have been observed. However, there are no known studies examining the efficacy of CPAP on cognition in MCI. Thus, if it is possible that OSA is identified and treated early, cognitive decline could be slowed or ameliorated. We hypothesise that CPAP will be associated with superior cognitive functioning in the domains of processing speed, memory and executive function, than compared to no treatment with CPAP.
Interventions
The intervention being studied in this trial is Continuous Positive Airway
Pressure (CPAP), which is the current gold-standard treatment for Obstructive Sleep Apnea (OSA). CPAP involves wearing a mask around the nose, mouth or face, which is connected via a tube to a device that creates an internal air pressure. This air pressure is then transmitted through the tube at a continuous pressure and into the mask worn by the participant every night during sleep.
CPAP dose is set by the air pressur
The intervention being studied in this trial is Continuous Positive Airway Pressure (CPAP), which is the current gold-standard treatment for Obstructive Sleep Apnea (OSA). CPAP involves wearing a mask around the nose, mouth or face, which is connected via a tube to a device that creates an internal air pressure. This air pressure is then transmitted through the tube at a continuous pressure and into the mask worn by the participant every night during sleep. CPAP dose is set by the air pressure emitted from the mask, and this will be determined by a pressure determination sleep test performed at the Woolcock Institute of Medical Research, in accordance with clinical practices. The duration of CPAP treatment will be for three months. Compliance with treatment will be measured using the built-in CPAP smartcard that will measure how long (in hours) the CPAP pump was used by the patient each time it was switched on. This information will be assessed during compliance appointments with an experienced CPAP therapist at regular intervals throughout the treatment period. Additionally, self-reported compliance will be assessed by a Study Researcher during structured telephone interviews conducted at Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16, 18, 20 and 24 during the active CPAP treatment period.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
To be eligible, participants must: 1. Have the presence of at least moderate OSA as defined by an AHI of greater than or equal to 15 as defined by PSG using the criteria of 4% O2 desaturation for events. 2. Have a diagnosis of single- or multi-domain Mild Cognitive Impairment (MCI) as determined by neuropsychological examination using a standardized research neuropsychological battery. 3. Have stability of at least four weeks on permitted medications (i.e. medications known not to affect sleep architecture or circadian rhythms). 4. Be fluent in English 5. Be willing and able to complete baseline, three month and six month outcome measures 6. Be willing to send in CPAP Smartcard for adherence testing
Exclusion criteria
Participants will be excluded if they have: 1. Suspected dementia or a score of <24 on the Mini-Mental State Examination 2. A history of cerebrovascular events (e.g., stroke, TIA) 3. Planned shift-work or transmeridian travel within timeline of study (six months from baseline) 4. A diagnosis of neurological disorders (e.g. Parkinson's Disease, Epilepsy, Multiple Sclerosis) 5. Head trauma with associated loss of consciousness > 30mins or head injury with persisting cognitive deficits 6. Psychiatric disorders including current major depression; Bipolar Disorder (I and II); schizophrenia 7. Been taking tricyclic antidepressants (TCAs), Monoamine Oxidase Inhibitors (MAOIs), benzodiazepines, sedative hypnotics, antipsychotics, mood stabilisers, modafinil or stimulants, cholinesterase inhibitors or medications known to affect sleep architecture and/or circadian rhythms (e.g. Lithium) 8. Current substance abuse or dependence (alcohol and/or other illicit substances) 9. Any significant systematic illness or medical condition that may hinder compliance with treatment protocol 10. Any current known conditions that may increase short-term risk from untreated OSA 11. Other known clinically significant sleep disorders (e.g. narcolepsy) 12. Been currently receiving CPAP or bi-level pressure for OSA 13. Requirements of oxygen or bi-level pressure during the CPAP titration PSG (PSG used to determine specifications for CPAP administration)
Outcome results
None listed