ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of patients who complete sleep testing
研究概览
简要总结
Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI/AD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI/AD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI/AD. Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of cognitive impairment by any one of: (i) Montreal Cognitive Assessment (MoCA) score of 13-28, or (ii) Mini Mental State Examination (MMSE) score of 18-30, or (iii) Toronto Cognitive Assessment (TorCA) score ≤
- •A diagnosis of: (i) Single-domain amnestic or multiple cognitive domain (with one feature being amnestic) Mild Cognitive Impairment due to Alzheimer's disease (AD); or (ii) Probable AD dementia; or (iii) Possible AD dementia due to limited concomitant cerebrovascular disease; or (iv) Probable Vascular dementia or Vascular Mild Cognitive Impairment, as per the 2011 American Heart Association Scientific Statement; or (v) Patients with a suspected neurodegenerative condition known to be associated with non-OSA sleep disorders (e.g. Parkinson's disease-related dementia and dementia with Lewy Bodies); and/or (vi) Mixed disease
- •Have the competency to provide informed consent, or the availability of a substitute decision maker/caregiver who can provide consent (if needed).
- •The availability of a caregiver to assist in the completion of HSAT or iPSG, if needed.
排除标准
- •Prior diagnosis of OSA within the last 2 years
- •Patients already using CPAP or a dental appliance for previously diagnosed OSA.
- •A known contraindication for the use of the HSAT that will be used in this study: (a) Moderate to severe pulmonary disease or congestive heart failure that could compromise the validity of the HSAT results (in users of the ApneaLink); (b) Permanent pacemaker or history of sustained non-sinus cardiac arrhythmia (in users of the WatchPAT).
- •Any medical device that would interfere with the placement of the HSAT
- •Significant physical impairment or language barrier that would restrict the ability to use the HSAT or complete the study assessments.
研究组 & 干预措施
Standard of Care
Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.
干预措施: In-laboratory polysomnography (Device)
Home Sleep Apnea Test
Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.
干预措施: Home Sleep Apnea Test (Device)
结局指标
主要结局
Proportion of patients who complete sleep testing
时间窗: 6 months
Proportion of patients who complete sleep testing by 6 months
次要结局
- Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)(6 months)
- Proportion of patients diagnosed with OSA and treated using CPAP(6 months)
- Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)(6 months)
- Mood (as assessed by the Geriatric Depression Scale)(6 months)
- Patient satisfaction for each strategy and treatment (as assessed by a Likert scale)(6 months)
- Health Related Quality of Life (as assessed by the EQ-5D-5L)(6 months)
- Cost to deliver each management strategy and treatment(6 months)
- Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)(6 months)
- Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)(6 months)