CPAP Randomized Controlled Trial

NCT06773416 | Not Yet Recruiting FDA Device

• 2 other identifiers: CTO 5040BH-10967
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this randomized controlled trial is to test the hypothesis that in older adults with mild cognitive impairment (MCI) and previously untreated obstructive sleep apnea (OSA), 4 months of web-based sleep education and continuous positive airway pressure (CPAP) will improve cognitive function more than web-based sleep education alone. Secondarily, this trial will test the hypothesis that 8 months of CPAP will improve cognitive function more than 4 months of CPAP. Moreover, treating OSA with CPAP can improve cognitive function and reduce Alzheimer's disease-related brain changes in older adults with MCI. 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. 1.Complete web-based sleep education modules through the Brain Health Pro (BHP) platform
2. 2.Undergo CPAP therapy, including in-person mask fitting and regular monitoring alongside a study sleep technologist

Conditions

Obstructive Sleep Apnea (OSA); Mild Cognitive Impairment (MCI); Cognitive Decline Prevention in Pre-frail Older Adults

Keywords

Obstructive Sleep Apnea; Cognitive Decline; CPAP Therapy; Mild Cognitive Impairment; Dementia Prevention; Sleep Education; Brain Health; Cognitive Function; Randomized Controlled Trial; CPAP Adherence; Older Adults; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change in Symbol Digit Modalities Test (SDMT)

  The SDMT is a test of speeded executive function that is predictive of clinically significant improvement in patients with MCI with a well-defined minimal clinically significant change and that is responsive to CPAP in observational studies. 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).

  From Week 0 to Week 32

Secondary Outcomes (2)

• Vascular Risk Factors and AD-biomarkers

  From Week 0 to Week 32

• MRI

  From Week 0 to Week 16

Study Arms (2)

Group 1 (Early CPAP group)

EXPERIMENTAL

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.

Combination Product: CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health

Group 2 (Later CPAP group)

ACTIVE COMPARATOR

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.

Combination Product: Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health

Interventions

CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health COMBINATION_PRODUCT

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 1 (Early CPAP group)

Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health COMBINATION_PRODUCT

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.

Group 2 (Later CPAP group)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained and signed
• 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.

You may not qualify if:

• drowsiness-related driving accidents or near misses in the past 12 months
• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Baycrest: collaborator
• University Health Network, Toronto: collaborator
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Andrew Lim, MD

CONTACT

416-480-6100; andrew.lim@sunnybrook.ca

Andrew Centen, MSc

CONTACT

416-480-5143; andrew.centen@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized into two groups: Group 1 is an Early CPAP group and Group 2 is a Later CPAP group. Group 1 begins CPAP therapy alongside web-based sleep education from baseline whereas Group 2 starts CPAP therapy after 4 months of web-based sleep education, similar to current clinical practices.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)