ACTRN12614000442606终止未知
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
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 80 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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