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Clinical Trials/ACTRN12614000442606
ACTRN12614000442606
Terminated
N/A

Treatment with Continuous Positive Airway Pressure in people aged 50-80 years with Obstructive Sleep Apnoea and Mild Cognitive Impairment to reduce the rate of cognitive decline

niversity of Sydney0 sites29 target enrollmentApril 29, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Sydney
Enrollment
29
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 29, 2014
End Date
September 4, 2019
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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