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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
200
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
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.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGProportion of patients who complete sleep testing
Proportion of patients who complete sleep testing by 6 months
Time frame: 6 months
Proportion of patients diagnosed with OSA and treated using CPAP
Proportion of patients diagnosed with OSA and treated using CPAP by 6 months
Time frame: 6 months
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months
Time frame: 6 months
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months
Time frame: 6 months
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) at 6 months
Time frame: 6 months
Mood (as assessed by the Geriatric Depression Scale)
Mood (as assessed by the Geriatric Depression Scale) at 6 months
Time frame: 6 months
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months
Time frame: 6 months
Health Related Quality of Life (as assessed by the EQ-5D-5L)
Health Related Quality of Life (as assessed by the EQ-5D-5L) at 6 months
Time frame: 6 months
Patient satisfaction for each strategy and treatment (as assessed by a Likert scale)
Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) at 6 months
Time frame: 6 months
Cost to deliver each management strategy and treatment
Cost to deliver each management strategy and treatment by 6 months
Time frame: 6 months
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