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

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.

Conditions

• Obstructive Sleep Apnea
• Alzheimer Disease
• Vascular Dementia
• Mild Cognitive Impairment
• Parkinsons Disease With Dementia
• Dementia With Lewy Bodies
• Mixed Dementia

Interventions

DEVICE

In-laboratory polysomnography

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

DEVICE

Home 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.

Sponsors & Collaborators

• Unity Health Toronto

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  lead OTHER

Principal Investigators

• Mark I Boulos, MD, MSc · University of Toronto and Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-23

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• Canada

Study Locations