Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Cognitive Ability in HIV+ Individuals With Obstructive Sleep Apnea (OSA): A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in Cognitive Performance measure (B-CAM)
研究概览
简要总结
Obstructive sleep apnea (OSA) is a breathing disorder that is characterized by episodes of complete or partial cessation of respiration during sleep, associated with upper airway collapse, oxygen desaturation and sleep fragmentation. OSA is a condition frequently implicated in cognitive disturbances, as well as associated with health conditions such as hypertension, metabolic disturbances and heightened risk of heart disease, stroke and mortality. These conditions are also increased in persons living with HIV. Individuals suffering from OSA report an increase in daytime sleepiness, mood changes and decline in quality of life.OSA also portends economic and societal impact through lost productivity at work and motor vehicle accidents. The presence of OSA is therefore important to detect in those living with HIV as it is potentially treatable contributors to cognitive disturbances in HIV. Continuous Positive Airway Pressure (CPAP) is the recommended treatment of choice for OSA. CPAP has established efficacy in improving cognition (executive function, long-term verbal and visual memory, attention/vigilance and global cognitive functioning). Although CPAP has been associated with improvements in cognitive functioning in the general population, its effectiveness in improving cognition in HIV+ individuals has never been previously tested. Given that cognitive disturbances in this population are multi-factorial, determining whether treatment of OSA in this population improves cognition is key in improving the clinical management of HIV+ individuals, both for its negative impact on cognition, but also more generally for their health.
详细描述
Definition of obstructive sleep apnea:
Obstructive sleep apnea (OSA) is a breathing disorder that is characterized by episodes of complete or partial cessation of respiration during sleep, associated with upper airway collapse, oxygen desaturation and sleep fragmentation. The index commonly used to assess sleep disordered breathing (SDB) is the respiratory disturbance index (RDI), defined as the average number of respiratory disturbances (obstructive apneas, hypopneas, and respiratory event-related arousals [RERAs]) per hour. According to the Centers for Medicare & Medicaid Services criteria for the positive diagnosis and treatment of obstructive sleep apnea, a positive test for OSA is established if the RDI ≥ 15 events per hour.
Obstructive sleep apnea and cognition:
Obstructive sleep apnea (OSA) is a condition frequently implicated in cognitive disturbances. These cognitive deficits are common : for example, in a meta-analysis of individuals with OSA, information processing speed was reduced in as many as 75% of individuals compared with norm-referenced data. In addition to its negative impact on cognition, OSA is associated with health conditions such as hypertension, metabolic disturbances (including impaired glucose tolerance, insulin resistance and dyslipidemia) and heightening risk of heart disease, stroke and mortality, conditions also increased in persons living with HIV. Individuals suffering from OSA report an increase in daytime sleepiness, mood changes and decline in quality of life. OSA also portends economic and societal impact through lost productivity at work and motor vehicle accidents.The presence of OSA is therefore important to detect in those living with HIV as it is a potentially treatable contributors to cognitive disturbances in HIV.
Obstructive sleep apnea and HIV:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in the cohort study "Understanding and Optimizing Brain Health in HIV Now"
- •Screened positive for OSA using the Berlin or the STOP-BANG (completed as part of the main study visits)
- •Have been on a stable HAART regimen for > 6 months
- •B-CAM ≤ 29
- •Have not had a change in medications that could potentially interfere with sleep or cognition in the past 4 months.
- •Willing to use CPAP as per instructions
- •Able to comply with follow-up visit assessments
- •Able to communicate in English or French
- •Have at least one remaining visit in the main cohort study
排除标准
- •Already treated for OSA
- •Ongoing involvement in night shift work
- •Presence of restless legs syndrome requiring immediate specific treatment
结局指标
主要结局
Changes in Cognitive Performance measure (B-CAM)
时间窗: Up to 5 months before the beginning of the intervention and up to 1 month after the end of the intervention.
The research team will be looking at changes on the B-CAM (brief cognitive ability measure) pre- and post-intervention
次要结局
- Adherence to the CPAP treatment(During the treatment (between 4 to 7 months))
- Changes Self-reported cognitive difficulties (C3Q)(One week before the beginning of the intervention and up to 4 weeks after the end of the intervention)
研究者
Marie-Josée Brouillette
Associate professor
McGill University