RecruitingNot ApplicableNCT04335994

ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing

ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

200 participants

Start Date

Sep 23, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is investigating whether sleep apnea — a condition where breathing repeatedly stops during sleep — is being missed in people with dementia or mild cognitive impairment (early memory problems), and whether treating it with a home sleep test and CPAP therapy improves their thinking and memory. Sleep apnea is common but often undiagnosed in people with cognitive problems. **You may be eligible if...** - You have been diagnosed with mild cognitive impairment or Alzheimer's disease (probable or possible), vascular dementia, or a related condition - Your memory or thinking difficulties are in a mild-to-moderate range based on standard tests - A caregiver is available to help you complete the sleep test if needed - You or your substitute decision-maker can provide informed consent **You may NOT be eligible if...** - You were already diagnosed with obstructive sleep apnea in the last 2 years - You are already using a CPAP machine or dental appliance for sleep apnea - You have a lung or heart condition that would make the home sleep test unreliable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIn-laboratory polysomnography

Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.

DEVICEHome Sleep Apnea Test

Use of a home sleep apnea test that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea.


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT04335994


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