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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04335994

Collaborator

Unity Health Toronto (Other)

122

Enrollment

Location

Arms

56.3

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Alzheimer Disease Vascular Dementia Mild Cognitive Impairment Parkinsons Disease With Dementia Dementia With Lewy Bodies Mixed Dementia	Device: In-laboratory polysomnography Device: Home Sleep Apnea Test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 23, 2019

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proportion of patients who complete sleep testing [6 months]
Proportion of patients who complete sleep testing by 6 months

Secondary Outcome Measures

Proportion of patients diagnosed with OSA and treated using CPAP [6 months]
Proportion of patients diagnosed with OSA and treated using CPAP by 6 months
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) [6 months]
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) [6 months]
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) [6 months]
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) at 6 months
Mood (as assessed by the Geriatric Depression Scale) [6 months]
Mood (as assessed by the Geriatric Depression Scale) at 6 months
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) [6 months]
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months
Health Related Quality of Life (as assessed by the EQ-5D-5L) [6 months]
Health Related Quality of Life (as assessed by the EQ-5D-5L) at 6 months
Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) [6 months]
Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) at 6 months
Cost to deliver each management strategy and treatment [6 months]
Cost to deliver each management strategy and treatment by 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.