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NCT Number: NCT04335994

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Alzheimer Disease Apnea Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dementia Dementia With Lewy Bodies Dementia, Vascular Dyssomnias Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Mental Disorders Mild Cognitive Impairment Mixed Dementia Mixed Dementias Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Parkinsons Disease With Dementia Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Synucleinopathies Tauopathies Vascular Dementia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location status: Recruiting

Location contact

Mark I Boulos, MD, MSc

CONTACT

[email protected]

4164804473

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-laboratory polysomnography

Device

Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.

Other names: iPSG

Home Sleep Apnea Test

Device

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

Primary outcomes

  1. Proportion of patients who complete sleep testing

    Time frame: 6 months

    Proportion of patients who complete sleep testing by 6 months

Secondary outcomes

  1. Proportion of patients diagnosed with OSA and treated using CPAP

    Time frame: 6 months

    Proportion of patients diagnosed with OSA and treated using CPAP by 6 months

  2. Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)

    Time frame: 6 months

    Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months

  3. Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)

    Time frame: 6 months

    Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months

  4. Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)

    Time frame: 6 months

    Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) at 6 months

  5. Mood (as assessed by the Geriatric Depression Scale)

    Time frame: 6 months

    Mood (as assessed by the Geriatric Depression Scale) at 6 months

  6. Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)

    Time frame: 6 months

    Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months

  7. Health Related Quality of Life (as assessed by the EQ-5D-5L)

    Time frame: 6 months

    Health Related Quality of Life (as assessed by the EQ-5D-5L) at 6 months

  8. Patient satisfaction for each strategy and treatment (as assessed by a Likert scale)

    Time frame: 6 months

    Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) at 6 months

  9. Cost to deliver each management strategy and treatment

    Time frame: 6 months

    Cost to deliver each management strategy and treatment by 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mark I Boulos, MD, MSc

CONTACT

[email protected]

4164804473

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Unity Health Toronto

Registry information

Official study title

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

Acronym: ENCHANT

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Apr 7, 2020
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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