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

Alzheimer Disease Clinical Trial

— ENCHANT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335994
• Other study ID #: 090-2019
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Mark I Boulos, MD, MSc
• Phone: 4164804473
• Email: mark.boulos[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Apnea
• Cognitive Dysfunction
• Dementia
• Dementia With Lewy Bodies
• Dementia, Vascular
• Lewy Body Disease
• Mild Cognitive Impairment
• Mixed Dementia
• Obstructive Sleep Apnea
• Parkinson Disease
• Parkinsons Disease With Dementia
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Vascular Dementia

Intervention

Device:
• In-laboratory polysomnography
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who complete sleep testing	Proportion of patients who complete sleep testing by 6 months	6 months
Secondary	Proportion of patients diagnosed with OSA and treated using CPAP	Proportion of patients diagnosed with OSA and treated using CPAP by 6 months	6 months
Secondary	Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)	Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months	6 months
Secondary	Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)	Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months	6 months
Secondary	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	6 months
Secondary	Mood (as assessed by the Geriatric Depression Scale)	Mood (as assessed by the Geriatric Depression Scale) at 6 months	6 months
Secondary	Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)	Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	Cost to deliver each management strategy and treatment	Cost to deliver each management strategy and treatment by 6 months	6 months