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

NCT04335994 | Recruiting

• 1 other identifier: 090-2019
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Obstructive Sleep Apnea; Cognitive Impairment; Home Sleep Apnea Test; Screening

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who complete sleep testing

  Proportion of patients who complete sleep testing by 6 months

  6 months

Secondary Outcomes (9)

• Proportion of patients diagnosed with OSA and treated using CPAP

  6 months

• Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)

  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

• Mood (as assessed by the Geriatric Depression Scale)

  6 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Device: In-laboratory polysomnography

Home Sleep Apnea Test

EXPERIMENTAL

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

Device: Home Sleep Apnea Test

Interventions

In-laboratory polysomnography DEVICE

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

Also known as: iPSG

Standard of Care

Home Sleep Apnea Test 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.

Also known as: HSAT

Home Sleep Apnea Test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Unity Health Toronto: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Alzheimer Disease; Dementia, Vascular; Cognitive Dysfunction; Lewy Body Disease; Mixed Dementias

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Mark I Boulos, MD, MSc

  University of Toronto and Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark I Boulos, MD, MSc

CONTACT

4164804473; mark.boulos@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 7, 2020
• Study Start: September 23, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)