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

NCT ID: NCT04335994

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2027-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.

Group Type: ACTIVE_COMPARATOR

In-laboratory polysomnography

Intervention Type: DEVICE

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

Home Sleep Apnea Test

Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.

Group Type: EXPERIMENTAL

Home Sleep Apnea Test

Intervention Type: DEVICE

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.

Interventions

In-laboratory polysomnography

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

iPSG; HSAT

Eligibility Criteria

Inclusion Criteria

• 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 ≤281.
• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark I Boulos, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Toronto and Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mark I Boulos, MD, MSc

Role: CONTACT

mark.boulos@sunnybrook.ca

4164804473

Facility Contacts

Mark I Boulos, MD, MSc

Role: primary

mark.boulos@sunnybrook.ca

4164804473

Other Identifiers

090-2019

Identifier Type: -

Identifier Source: org_study_id