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Obstructive Sleep Apnea (OSA)NCT06773416

CPAP Randomized Controlled Trial

A study testing CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health and Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health in people with Obstructive Sleep Apnea (OSA) and Mild Cognitive Impairment (MCI), run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health and Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteCanada
Study dates
Feb 2025to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew Lim, MD contact

416-480-6100 ext. 5753

andrew.lim@sunnybrook.ca

Andrew Centen, MSc contact

416-480-5143

andrew.centen@sunnybrook.ca

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Andrew Lim, MD, 416-480-6100 ext. 5753, andrew.lim@sunnybrook.ca

    Andrew Centen, MSc, 416-480-5143, andrew.centen@sunnybrook.ca

Other trials in Canada

About this study

Official title: Treating Sleep Apnea to Improve Cognitive Function, Alzheimer's Disease Pathology, and Astrocyte Activation in Older Adults With Cognitive Impairment: A Multi-Centre Randomized Controlled Trial

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.

Read more

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).

Read the detailed description

This clinical study is a single-blinded, randomized controlled trial of 206 adults designed to evaluate the impact of CPAP therapy on cognitive function and Alzheimer's disease-related pathology in older adults with MCI and untreated OSA. Participants will be randomized into two groups: the first group receiving CPAP treatment alongside sleep education upon enrollment for 8 months (Early CPAP group) and the other beginning CPAP treatment after 4 months of sleep education (Later CPAP group).

  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.

Being tested
CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health, Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health
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&#39;s Disease
Medical subject headings
Sleep Apnea, Obstructive, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep HealthCombination 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.

  • Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep HealthCombination 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.

Study groups in NCT06773416
Study groupRoleWhat they receive
Group 1 (Early CPAP group)ExperimentalParticipant 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.
Receives: Combination Product: CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health
Group 2 (Later CPAP group)Active comparatorParticipant 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.
Receives: Combination Product: Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From Week 0 to Week 32

Secondary outcomes (2)

  1. Vascular Risk Factors and AD-biomarkers

    Quantification of plasma pTau181 (AD pathology) using ptau-181 V2.1 Advantage Assay and GFAP (astrocyte activation) using the GFAP discovery assay.

    Blood levels of various fats, sugars and proteins (such as cholesterol or glucose) will be assessed.

    Sleep physiology will be assessed using wearable sensors: at-home sleep apnea testing apparatus (for oximetry metrics including AHI, ODI, mean SpO2, hypoxia burden, and time with O2<92%), EEG headband (sleep staging, including % slow wave sleep, % REM sleep, total EEG sleep time, and NREM slow wave power), and wrist-worn accelerometry (for total sleep time and sleep fragmentation).

    Measured: From Week 0 to Week 32

  2. MRI

    Participants will undergo MRI using the Canadian Dementia Imaging protocol consisting of a 3D T1, interleaved 3mm PD/T2, 3D FLAIR, T2*, DTI, and resting state BOLD. Perivascular spaces and white matter hyperintensities will be quantified with the SynthSegCSVD algorithm developed and validated in our laboratory, a robust neural network based tool.

    Measured: From Week 0 to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study startFeb 2025 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773416
Sponsor's protocol ID
CTO 5040
Other IDs
BH-10967
Status last verified
Dec 2024
First submitted
8 Jan 2025
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Hedner J, White DP, Malhotra A, Herscovici S, Pittman SD, Zou D, Grote L, Pillar G. Sleep staging based on autonomic signals: a multi-center validation study. J Clin Sleep Med. 2011 Jun 15;7(3):301-6. doi: 10.5664/JCSM.1078.

    PubMed 21677901

  • Onder NS, Akpinar ME, Yigit O, Gor AP. Watch peripheral arterial tonometry in the diagnosis of obstructive sleep apnea: influence of aging. Laryngoscope. 2012 Jun;122(6):1409-14. doi: 10.1002/lary.23233. Epub 2012 Apr 20.

    PubMed 22522750

  • Crowley KE, Rajaratnam SM, Shea SA, Epstein LJ, Czeisler CA, Lockley SW; Harvard Work Hours, Health and Safety Group. Evaluation of a single-channel nasal pressure device to assess obstructive sleep apnea risk in laboratory and home environments. J Clin Sleep Med. 2013 Feb 1;9(2):109-16. doi: 10.5664/jcsm.2400.

    PubMed 23372462

  • Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

    PubMed 5349366

  • Benedict RHB, Schretlen D, Groninger L, &amp; Brandt J (1998). Hopkins Verbal Learning Test - Revised: Normative Data and Analysis of Inter-Form and Test-Retest Reliability. The Clincal Neuropsychologist, 12(1), 43-55.

  • Wechsler D. The Psychological Corporation; 1997. WMS-III Administration and Scoring Manual.

  • Esther Strauss, O. S. (1998). Trail Making Tests. New York, Oxford University Press.

  • Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.

    PubMed 7183759

  • DOPPELT JE, WALLACE WL. Standardization of the Wechsler adult intelligence scale for older persons. J Abnorm Psychol. 1955 Sep;51(2):312-30. doi: 10.1037/h0044391. No abstract available.

    PubMed 13263050

  • Chapman JE, Cadilhac DA, Gardner B, Ponsford J, Bhalla R, Stolwyk RJ. Comparing face-to-face and videoconference completion of the Montreal Cognitive Assessment (MoCA) in community-based survivors of stroke. J Telemed Telecare. 2021 Sep;27(8):484-492. doi: 10.1177/1357633X19890788. Epub 2019 Dec 9.

    PubMed 31813317

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Boeve BF, Molano JR, Ferman TJ, Smith GE, Lin SC, Bieniek K, Haidar W, Tippmann-Peikert M, Knopman DS, Graff-Radford NR, Lucas JA, Petersen RC, Silber MH. Validation of the Mayo Sleep Questionnaire to screen for REM sleep behavior disorder in an aging and dementia cohort. Sleep Med. 2011 May;12(5):445-53. doi: 10.1016/j.sleep.2010.12.009. Epub 2011 Feb 23.

    PubMed 21349763

  • Allen RP, Burchell BJ, MacDonald B, Hening WA, Earley CJ. Validation of the self-completed Cambridge-Hopkins questionnaire (CH-RLSq) for ascertainment of restless legs syndrome (RLS) in a population survey. Sleep Med. 2009 Dec;10(10):1097-100. doi: 10.1016/j.sleep.2008.10.007. Epub 2009 Feb 4.

    PubMed 19195928

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PubMed 11438246

  • Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.

    PubMed 26378880

Questions about this trial

What is this clinical trial studying?

A study testing CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health and Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health in people with Obstructive Sleep Apnea (OSA) and Mild Cognitive Impairment (MCI), run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew Lim, MD (416-480-6100 ext. 5753, andrew.lim@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Symbol Digit Modalities Test (SDMT) (time frame: From Week 0 to Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06773416, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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