Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
206 participants
INTERVENTIONAL
2025-02-28
2028-01-31
Brief Summary
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This study will compare an Early CPAP Group who will receive CPAP and sleep education simultaneously for 8 months upon enrollment to a Later CPAP Group who will first receive sleep education for 4 months followed by CPAP and sleep education for the next 4 months to test if early treatment is more beneficial.
Participants will:
1. Complete web-based sleep education modules through the Brain Health Pro (BHP) platform
2. Undergo CPAP therapy, including in-person mask fitting and regular monitoring alongside a study sleep technologist
At 0 months, 4 months, and 8 months, participants will participate in cognitive assessments, provide blood samples, use wearable devices to measure sleep patterns and physiology, and complete a 1-hr MRI (0 months and 4 months only).
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Detailed Description
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1. Early CPAP Group: Participants randomized to this group will start BHP-sleep and CPAP simultaneously and continue both for 8 months. BHP-sleep consists of the sleep modules of the Canadian Consortium on Neurodegeneration in Aging's (CCNA) online Brain Health PRO platform covering sleep physiology, healthy sleep habits, and information about sleep disorders like sleep apnea. Participants will receive a study-provided auto-titrating CPAP device, with settings set by one of the study sleep medicine physicians according to current clinical practice parameters. Participants will undergo an in-person mask fitting, and then will be supported by a sleep technologist with extensive clinical experience with CPAP.
2. Later CPAP Group: Participants randomized to this group will start BHP-sleep without CPAP for first 4 months, followed by BHP-sleep and CPAP simultaneously for remaining 4 months of participation.
Participants in both groups will register at baseline for the web-based sleep education through the Brain Health Pro (BHP) platform; a 45-week, multidomain, web-based formal educational program designed to increase dementia literacy, foster engagement, and convey best available evidence for lifestyle changes that can mitigate dementia risk. This protocol will utilize the sleep modules of the BHP platform covering sleep physiology, healthy sleep habits, and information about sleep disorders like sleep apnea.
This trial will assess cognitive function primarily using the Symbol Digit Modalities Test (SDMT); a test of speeded executive function that is predictive of clinically significant improvement in patients with MCI, alongside additional cognitive measures that supplement the primary outcome of this study will be: attention and executive function (Trail Making Test A \& B), working memory (Digit Span and Letter-Number Sequencing), verbal learning and memory (Hopkins Verbal Learning Test), and severity of cognitive impairment (Alzheimer's Disease Assessment Scale - Cognitive Subscale; ADAS-Cog-13).
This trial will also quantify brain perivascular spaces (PVS) volume and structural changes, plasma glial fibrillary acidic protein (GFAP) and plasma pTau-181.
This trial will also aim to identify features of sleep physiology that mediate the impact of CPAP on cognitive function.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1 (Early CPAP group)
Participant will receive a study-provided CPAP device at their baseline visit, with settings set by one of the study sleep medicine physicians according to current clinical practice parameters. Participant will undergo an in-person mask fitting and then will be supported by a study sleep technologist with extensive clinical experience with CPAP who will contact the participant by telephone or video call at set intervals. Masks, tubing, chin straps, and other equipment necessary to optimize CPAP adherence will be provided by the study. Adherence will be monitored through downloads from the CPAP device. Participant will be asked to use CPAP nightly during their participation in this study. Participant will simultaneously participate in web-based sleep education through the Brain Health Pro (BHP) platform; a formal educational program designed to increase dementia literacy, foster engagement, and convey best available evidence for lifestyle changes that can mitigate dementia risk.
CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health
Participants in Group 1 will receive CPAP therapy immediately upon enrollment alongside web-based sleep education through the Brain Health Pro (BHP) platform. The CPAP intervention includes a study-provided auto-titrating device, in-person mask fitting, and ongoing support from a study sleep technologist. Adherence will be monitored via remote data uploads. The BHP platform is a 45-week web-based formal educational program program designed to increase dementia literacy, foster engagement, and convey best available evidence for lifestyle changes that can mitigate dementia risk. This combined approach ensures simultaneous initiation of CPAP and educational reinforcement to optimize adherence and cognitive outcomes.
Group 2 (Later CPAP group)
Participant will receive the web-based sleep educational intervention first for 4 months. Participant will then receive a study-supplied CPAP device with settings set by one of the study sleep medicine physicians according to current clinical practice parameters. Participant will undergo an in-person mask fitting and will be supported by a study sleep technologist with extensive clinical experience with CPAP who will contact the participant by telephone or video call at set intervals. Equipment necessary to optimize CPAP adherence will be provided. Adherence will be monitored through downloads from the CPAP device. Participant will be asked to use CPAP nightly throughout their participation. Participant will simultaneously participate in web-based sleep education through the Brain Health Pro platform; a formal educational program designed to increase dementia literacy, foster engagement and convey best available evidence for lifestyle changes that can mitigate dementia risk.
Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health
Participants in Group 2 will begin with 4 months of BHP web-based sleep education before adding CPAP therapy for the remaining 4 months. CPAP setup and support are identical to the Early CPAP group. Participants in Group 2 will experience procedure similar to current clinical practices.
Interventions
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CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health
Participants in Group 1 will receive CPAP therapy immediately upon enrollment alongside web-based sleep education through the Brain Health Pro (BHP) platform. The CPAP intervention includes a study-provided auto-titrating device, in-person mask fitting, and ongoing support from a study sleep technologist. Adherence will be monitored via remote data uploads. The BHP platform is a 45-week web-based formal educational program program designed to increase dementia literacy, foster engagement, and convey best available evidence for lifestyle changes that can mitigate dementia risk. This combined approach ensures simultaneous initiation of CPAP and educational reinforcement to optimize adherence and cognitive outcomes.
Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health
Participants in Group 2 will begin with 4 months of BHP web-based sleep education before adding CPAP therapy for the remaining 4 months. CPAP setup and support are identical to the Early CPAP group. Participants in Group 2 will experience procedure similar to current clinical practices.
Eligibility Criteria
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Inclusion Criteria
* Age \>55
* MCI: Participants will undergo a video-based screening, including a clinical interview, Logical Memory II, MoCA, and Lawton-Brody Instrumental Activities of Daily Living Scale Score. A participant will be considered to have MCI if they have: 1) MoCA score of 13-24 and Logical Memory II Score ≤ 8 (\&=16 years of education), ≤ 4 (8-15 years of education) or ≤ 2 (0-7 years of education) and Lawton-Brody IADL Score \>14/23 and do not meet DSM IV criteria for dementia and have a change in self-perceived cognition from previous
* Moderate-severe OSA: Participants who screen positive for MCI will be mailed an at-home sleep apnea testing device. Participants with ODI≥5 will undergo in-lab polysomnography (PSG) for confirmation and characterization of sleep apnea. A participant will be considered to have moderate-severe OSA if they have on PSG: AHI\>15, and ODI\>10, and central apneas\<10% of all apneas, and periodic limb movement index \<15.
Exclusion Criteria
* drives as their primary occupation
* unable to complete cognitive evaluation in English
* unable to participate in video-based cognitive assessment
* not a resident of Ontario
* contraindications to MRI
* contraindications to CPAP or unwilling to start CPAP
* no available study partner to support CPAP
* previously treated for sleep apnea
* clinically significant insomnia (ISI \> 15), restless legs syndrome, or shift work
* taking disease modifying agents for MCI
55 Years
ALL
No
Sponsors
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Baycrest
OTHER
University Health Network, Toronto
OTHER
Centre for Addiction and Mental Health
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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BH-10967
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CTO 5040
Identifier Type: -
Identifier Source: org_study_id
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