Obstructive Sleep ApneaENCHANTNCT04335994
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
A study testing In-laboratory polysomnography and Home Sleep Apnea Test in people with Obstructive Sleep Apnea and Alzheimer Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea, Alzheimer Disease, Vascular Dementia
- What is being tested?
- In-laboratory polysomnography and Home Sleep Apnea Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2019to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Mark I Boulos, MD, MSc, 4164804473, mark.boulos@sunnybrook.ca
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea, Alzheimer Disease, Vascular Dementia, Mild Cognitive Impairment, Parkinsons Disease With Dementia, Dementia With Lewy Bodies
- Being tested
- In-laboratory polysomnography, Home Sleep Apnea Test
- Keywords
- Obstructive Sleep Apnea, Cognitive Impairment, Home Sleep Apnea Test, Screening
- Medical subject headings
- Sleep Apnea, Obstructive, Alzheimer Disease, Dementia, Vascular, Cognitive Dysfunction, Lewy Body Disease, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-laboratory polysomnographyDevice
Also called iPSG
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
Home Sleep Apnea TestDevice
Also called HSAT
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography. Receives: Device: In-laboratory polysomnography |
| Home Sleep Apnea Test | Experimental | Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test. Receives: Device: Home Sleep Apnea Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who complete sleep testing
Proportion of patients who complete sleep testing by 6 months
Measured: 6 months
Secondary outcomes (9)
Proportion of patients diagnosed with OSA and treated using CPAP
Proportion of patients diagnosed with OSA and treated using CPAP by 6 months
Measured: 6 months
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months
Measured: 6 months
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months
Measured: 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
Measured: 6 months
Mood (as assessed by the Geriatric Depression Scale)
Mood (as assessed by the Geriatric Depression Scale) at 6 months
Measured: 6 months
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months
Measured: 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
Measured: 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
Measured: 6 months
Cost to deliver each management strategy and treatment
Cost to deliver each management strategy and treatment by 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start23 Sep 2019
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- Mark I Boulos, MD, MSc, Principal investigator, University of Toronto and Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335994
- Sponsor's protocol ID
- 090-2019
- Acronym
- ENCHANT
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No