ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: In-laboratory polysomnography, Home Sleep Apnea Test.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea, Alzheimer Disease, Vascular Dementia, Mild Cognitive Impairment. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)
Overview
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.
Interventions
- Device In-laboratory polysomnography
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea. - 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.
Primary outcome measures
- Proportion of patients who complete sleep testing [Time frame: 6 months]
Secondary outcome measures (9)
- Proportion of patients diagnosed with OSA and treated using CPAP [Time frame: 6 months]
- Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) [Time frame: 6 months]
- Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) [Time frame: 6 months]
- Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) [Time frame: 6 months]
- Mood (as assessed by the Geriatric Depression Scale) [Time frame: 6 months]
- Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) [Time frame: 6 months]
- Health Related Quality of Life (as assessed by the EQ-5D-5L) [Time frame: 6 months]
- Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) [Time frame: 6 months]
- Cost to deliver each management strategy and treatment [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT04335994 · 090-2019