Clinical trial NCT04335994: ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
Official title: ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2020-04-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Proportion of patients who complete sleep testing
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients diagnosed with OSA and treated using CPAP
timeFrame: 6 months
measure: Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)
timeFrame: 6 months
measure: Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)
timeFrame: 6 months
measure: Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)
timeFrame: 6 months
measure: Mood (as assessed by the Geriatric Depression Scale)
timeFrame: 6 months
measure: Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
timeFrame: 6 months
measure: Health Related Quality of Life (as assessed by the EQ-5D-5L)
timeFrame: 6 months
measure: Patient satisfaction for each strategy and treatment (as assessed by a Likert scale)
timeFrame: 6 months
measure: Cost to deliver each management strategy and treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Toronto and Sunnybrook Health Sciences Centre
name: Mark I Boulos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: