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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335994
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 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 : September 23, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022


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 Name: 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 Name: HSAT




Primary Outcome Measures :
  1. Proportion of patients who complete sleep testing [ Time Frame: 6 months ]
    Proportion of patients who complete sleep testing by 6 months


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335994


Contacts
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Contact: Mark I Boulos, MD, MSc 4164804473 mark.boulos@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Mark I Boulos, MD, MSc    4164804473    mark.boulos@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Mark I Boulos, MD, MSc University of Toronto and Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04335994    
Other Study ID Numbers: 090-2019
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Obstructive Sleep Apnea
Cognitive Impairment
Home Sleep Apnea Test
Screening
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Parkinson Disease
Alzheimer Disease
Dementia
Dementia, Vascular
Lewy Body Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Tauopathies
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Cognition Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases