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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea; Alzheimer Disease; Mild Cognitive Impairment; Vascular Dementia; Dementia With Lewy Bodies; Mixed Dementia; Parkinsons Disease With Dementia
• Intervention / Treatment: Device: In-laboratory polysomnography; Device: Home Sleep Apnea Test

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.	Device: In-laboratory polysomnography; Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.; Other Names: iPSG
Experimental: Home Sleep Apnea Test; Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.	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.; Other Names: HSAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who complete sleep testing	Proportion of patients who complete sleep testing by 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients diagnosed with OSA and treated using CPAP	Proportion of patients diagnosed with OSA and treated using CPAP by 6 months	6 months
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)	Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months	6 months
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)	Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months	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	6 months
Mood (as assessed by the Geriatric Depression Scale)	Mood (as assessed by the Geriatric Depression Scale) at 6 months	6 months
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)	Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months	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	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	6 months
Cost to deliver each management strategy and treatment	Cost to deliver each management strategy and treatment by 6 months	6 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Unity Health Toronto
• Investigators: Principal Investigator: Mark I Boulos, MD, MSc, University of Toronto and Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Cognitive Impairment; Screening; Home Sleep Apnea Test
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Respiratory; Tauopathies; Cognition Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Parkinson Disease; Apnea; Dementia; Alzheimer Disease; Cognitive Dysfunction; Lewy Body Disease; Dementia, Vascular
• Other Study ID Numbers: 090-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No