Back to resultsENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing (ENCHANT)
Primary Purpose
Obstructive Sleep Apnea, Alzheimer Disease, Vascular Dementia
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
In-laboratory polysomnography
Home Sleep Apnea Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Cognitive Impairment, Home Sleep Apnea Test, Screening
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.
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Home Sleep Apnea Test
Arm Description
Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.
Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.
Outcomes
Primary Outcome Measures
Proportion of patients who complete sleep testing
Proportion of patients who complete sleep testing by 6 months
Secondary Outcome Measures
Proportion of patients diagnosed with OSA and treated using CPAP
Proportion of patients diagnosed with OSA and treated using CPAP by 6 months
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)
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)
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)
Mood (as assessed by the Geriatric Depression Scale) at 6 months
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 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
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
Cost to deliver each management strategy and treatment
Cost to deliver each management strategy and treatment by 6 months
Full Information
NCT ID
NCT04335994
First Posted
March 30, 2020
Last Updated
August 8, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04335994
Brief Title
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
Acronym
ENCHANT
Official Title
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.
Arm Title
Home Sleep Apnea Test
Arm Type
Experimental
Arm Description
Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.
Intervention Type
Device
Intervention Name(s)
In-laboratory polysomnography
Other Intervention Name(s)
iPSG
Intervention Description
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
Intervention Type
Device
Intervention Name(s)
Home Sleep Apnea Test
Other Intervention Name(s)
HSAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients who complete sleep testing
Description
Proportion of patients who complete sleep testing by 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of patients diagnosed with OSA and treated using CPAP
Description
Proportion of patients diagnosed with OSA and treated using CPAP by 6 months
Time Frame
6 months
Title
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)
Description
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months
Time Frame
6 months
Title
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)
Description
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months
Time Frame
6 months
Title
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)
Description
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) at 6 months
Time Frame
6 months
Title
Mood (as assessed by the Geriatric Depression Scale)
Description
Mood (as assessed by the Geriatric Depression Scale) at 6 months
Time Frame
6 months
Title
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Description
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months
Time Frame
6 months
Title
Health Related Quality of Life (as assessed by the EQ-5D-5L)
Description
Health Related Quality of Life (as assessed by the EQ-5D-5L) at 6 months
Time Frame
6 months
Title
Patient satisfaction for each strategy and treatment (as assessed by a Likert scale)
Description
Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) at 6 months
Time Frame
6 months
Title
Cost to deliver each management strategy and treatment
Description
Cost to deliver each management strategy and treatment by 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark I Boulos, MD, MSc
Organizational Affiliation
University of Toronto and Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
We'll reach out to this number within 24 hrs