SleepNCT03410095
The Brain Changes in Sleep Apnea Study
An observational study of Sleep and Sleep Apnea, run by Dr. Andrew Lim at 1 site in Canada.
Trial summary
Sleep is critical to human health, but insufficient and disrupted sleep caused by sleep apnea are common and have a major impact on brain health. However, there is still much that is not known about how sleep apnea damages the brain and what can be done to fix this. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Sleep Apnea, Sleep Apnea Syndromes
- What is being tested?
- Brain MRI, cognitive testing, bloodwork
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2018to 15 Jun 2022
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 adults with newly diagnosed severe sleep apnea will be recruited from the sleep clinics at Sunnybrook Health Sciences Centre (n=40) or the University of Edinburgh (n=40).
Who may be able to join
- Newly diagnosed sleep apnea not on CPAP or any other treatment for sleep apnea;
- Apnea hypopnea index >=15 on diagnostic polysomnogram;
- Oxygen desaturation index >=10 or O2 saturation in sleep <90% for >15 minutes on diagnostic polysomnogram;
- Subjectively sleepy;
- Planning on starting CPAP for sleep apnea.
Who cannot join
- Known history of stroke, transient ischemic attack, or other CNS disease;
- Unable to safely undergo MRI;
- Use of alpha-blocking agents;
- Persistent non-sinus arrhythmia;
- Severe pulmonary or cardiac diseases including COPD and CHF;
- Waking spO2<90%;
- History of panic disorder.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Andrew Centen, MSc, 416-480-5143, sleepapneabrain@sunnybrook.ca
About this study
Sleep is critical to human health, but insufficient and disrupted sleep caused by sleep apnea are common and have a major impact on brain health. However, there is still much that is not known about how sleep apnea damages the brain and what can be done to fix this. The Brain Changes in Sleep Apnea Study will look at the brain health of people with severe sleep apnea both before and after 4 months of treatment with a CPAP machine. Pre- and post-CPAP treatment, 80 participants with severe sleep apnea will undergo cognitive testing, blood and urine tests, a pulse wave velocity test, and an MRI. Also pre- and post-CPAP treatment, participants will wear a blood pressure monitor for 24 hours, wear an accelerometer watch for 8 nights to track the duration and quality of their sleep, and wear a device for 1 night of sleep to assess their breathing and blood oxygen levels. It is expected that there will be improvements in participants' brain health after 4 months of CPAP treatment.
Read the detailed description
Between January 2018 and February 2022, the Brain Changes in Sleep Apnea Study will recruit 80 adults with newly diagnosed severe sleep apnea attending the sleep clinics at Sunnybrook Health Sciences Centre (n=40) or the University of Edinburgh (n=40). Participants will undergo home-based assessment with 3 wearable devices (24 hours of ambulatory blood pressure monitoring, 8 nights of actigraphy to assess sleep duration and fragmentation, and 1 night of finger-probe peripheral arterial tonometry and oximetry to assess cardiorespiratory physiology including sleep apnea), completion of a sleep and health questionnaire, 24-hour collection of urine for assessing sympathetic nervous system activity, blood banking for endothelial biomarkers, cognitive evaluation, pulse wave velocity test, and an MRI of the brain, at 2 time points: 1) after initial polysomnographic diagnosis of sleep apnea but before the initiation of CPAP, and 2) after 4 months of CPAP treatment.
- Conditions
- Sleep, Sleep Apnea, Sleep Apnea Syndromes
- Being tested
- Brain MRI, cognitive testing, bloodwork
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRI, cognitive testing, bloodworkDiagnostic test
Participants will undergo 3-Tesla MRI. Scan time will be about 1 hour and 15 minutes per subject per session at the Sunnybrook site. The protocol is designed to image SVD burden by quantifying PVS and WMH volumes, and image various physiological estimates on the brain.
Participants will undergo the following cognitive tests: Behavioural Neurology Assessment-R (BNA-R), Montreal Cognitive Assessment (MOCA), Center for Epidemiologic Studies Depression Scale (CES-D), and BrainScreen.
Blood samples will be assayed for inflammatory and endothelial function. Classical vascular risk factors will also be assessed. Once data collection is complete, DNA will be extracted from the frozen PBMC fraction and will be genotyped for APOE genotype and a panel of other single nucleotide polymorphisms known to be associated with cognition and cerebrovascular disease.
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea patients | 80 patients recently diagnosed with severe sleep apnea will participate in the Brain Changes in Sleep Apnea Study. Receives: Diagnostic Test: Brain MRI, cognitive testing, bloodwork |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in perivascular space volume
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on perivascular space volume.
Measured: Baseline and 4 months
Change from baseline in DTI fractional anisotropy on voxel-wise basis
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on DTI fractional anisotropy on voxel-wise basis.
Measured: Baseline and 4 months
Change from baseline in a summary measure of arterial pulsatility
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on arterial pulsatility (as measured by the pulse wave velocity test).
Measured: Baseline and 4 months
Change from baseline in perivascular lactate measured by MR spectroscopy
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on perivascular lactate (as measured by MR spectroscopy).
Measured: Baseline and 4 months
Change from baseline in cerebrovascular reactivity on a voxel-wise basis
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on cerebrovascular reactivity on a voxel-wise basis.
Measured: Baseline and 4 months
Secondary outcomes (6)
Change from baseline in 24-hour blood pressure
We will quantify the main effect of CPAP treatment on 24-hour blood pressure (as measured by the ambulatory blood pressure monitor).
Measured: Baseline and 4 months
Change from baseline in sleep duration and fragmentation
We will quantify the main effect of CPAP treatment on sleep duration and fragmentation (as measured by the GENEActiv).
Measured: Baseline and 4 months
Change from baseline in severity of sleep apnea, % deep NREM sleep, and hypoxemia
We will quantify the main effect of CPAP treatment on severity of sleep apnea, % deep NREM sleep, and hypoxemia (as measured by the WatchPAT).
Measured: Baseline and 4 months
Change from baseline in serum markers of metabolic, inflammatory, cardiovascular, and endothelial function
We will quantify the main effect of CPAP treatment on serum markers of metabolic, inflammatory, cardiovascular, and endothelial function (as measured by blood tests).
Measured: Baseline and 4 months
Change from baseline in urinary measures of sympathetic nervous system
We will quantify the main effect of CPAP treatment on urinary measures of sympathetic nervous system (as measured with urine test).
Measured: Baseline and 4 months
Change from baseline in cognitive performance
We will quantify the main effect of CPAP treatment on cognitive performance (as measured by our computerized battery, which includes the MoCA, BNA-R, and BrainScreen).
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start12 Dec 2018
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Dr. Andrew Lim
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh
- Responsible party
- Sponsor-investigator, Dr. Andrew Lim, Sunnybrook Health Sciences Centre
- Investigators
- Andrew Lim, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410095
- Sponsor's protocol ID
- SleepApneaStudy
- Status last verified
- Mar 2021
- First submitted
- 19 Dec 2017
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434Ancoli-Israel S, Kripke DF, Klauber MR, Mason WJ, Fell R, Kaplan O. Sleep-disordered breathing in community-dwelling elderly. Sleep. 1991 Dec;14(6):486-95. doi: 10.1093/sleep/14.6.486.
PubMed 1798880Yaffe K, Laffan AM, Harrison SL, Redline S, Spira AP, Ensrud KE, Ancoli-Israel S, Stone KL. Sleep-disordered breathing, hypoxia, and risk of mild cognitive impairment and dementia in older women. JAMA. 2011 Aug 10;306(6):613-9. doi: 10.1001/jama.2011.1115.
PubMed 21828324Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25.
PubMed 20339144Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.
PubMed 24136970Kim H, Yun CH, Thomas RJ, Lee SH, Seo HS, Cho ER, Lee SK, Yoon DW, Suh S, Shin C. Obstructive sleep apnea as a risk factor for cerebral white matter change in a middle-aged and older general population. Sleep. 2013 May 1;36(5):709-715B. doi: 10.5665/sleep.2632.
PubMed 23633753Lim AS, Yu L, Schneider JA, Bennett DA, Buchman AS. Sleep Fragmentation, Cerebral Arteriolosclerosis, and Brain Infarct Pathology in Community-Dwelling Older People. Stroke. 2016 Feb;47(2):516-8. doi: 10.1161/STROKEAHA.115.011608. Epub 2016 Jan 14.
PubMed 26768207Berezuk C, Ramirez J, Gao F, Scott CJ, Huroy M, Swartz RH, Murray BJ, Black SE, Boulos MI. Virchow-Robin Spaces: Correlations with Polysomnography-Derived Sleep Parameters. Sleep. 2015 Jun 1;38(6):853-8. doi: 10.5665/sleep.4726.
PubMed 26163465Malhotra A, Younes M, Kuna ST, Benca R, Kushida CA, Walsh J, Hanlon A, Staley B, Pack AI, Pien GW. Performance of an automated polysomnography scoring system versus computer-assisted manual scoring. Sleep. 2013 Apr 1;36(4):573-82. doi: 10.5665/sleep.2548.
PubMed 23565003Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.
PubMed 24918372Martinez-Garcia MA, Capote F, Campos-Rodriguez F, Lloberes P, Diaz de Atauri MJ, Somoza M, Masa JF, Gonzalez M, Sacristan L, Barbe F, Duran-Cantolla J, Aizpuru F, Manas E, Barreiro B, Mosteiro M, Cebrian JJ, de la Pena M, Garcia-Rio F, Maimo A, Zapater J, Hernandez C, Grau SanMarti N, Montserrat JM; Spanish Sleep Network. Effect of CPAP on blood pressure in patients with obstructive sleep apnea and resistant hypertension: the HIPARCO randomized clinical trial. JAMA. 2013 Dec 11;310(22):2407-15. doi: 10.1001/jama.2013.281250.
PubMed 24327037Hachinski V; World Stroke Organization. Stroke and Potentially Preventable Dementias Proclamation: Updated World Stroke Day Proclamation. Stroke. 2015 Nov;46(11):3039-40. doi: 10.1161/STROKEAHA.115.011237. No abstract available.
PubMed 26504189Kress BT, Iliff JJ, Xia M, Wang M, Wei HS, Zeppenfeld D, Xie L, Kang H, Xu Q, Liew JA, Plog BA, Ding F, Deane R, Nedergaard M. Impairment of paravascular clearance pathways in the aging brain. Ann Neurol. 2014 Dec;76(6):845-61. doi: 10.1002/ana.24271. Epub 2014 Sep 26.
PubMed 25204284Jessen NA, Munk AS, Lundgaard I, Nedergaard M. The Glymphatic System: A Beginner's Guide. Neurochem Res. 2015 Dec;40(12):2583-99. doi: 10.1007/s11064-015-1581-6. Epub 2015 May 7.
PubMed 25947369Achariyar TM, Li B, Peng W, Verghese PB, Shi Y, McConnell E, Benraiss A, Kasper T, Song W, Takano T, Holtzman DM, Nedergaard M, Deane R. Glymphatic distribution of CSF-derived apoE into brain is isoform specific and suppressed during sleep deprivation. Mol Neurodegener. 2016 Dec 8;11(1):74. doi: 10.1186/s13024-016-0138-8.
PubMed 27931262
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brain Changes in Sleep Apnea Study
- ClinicalTrials.gov ID
- NCT03410095
- Acronym / sponsor ID
- SleepApneaStudy
- Conditions
- Sleep, Sleep Apnea, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Andrew LimUniversity, hospital or other
- Collaborators
- University of Edinburgh
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep is critical to human health, but insufficient and disrupted sleep caused by sleep apnea are common and have a major impact on brain health. However, there is still much that is not known about how sleep apnea damages the brain and what can be done to fix this. The Brain Changes in Sleep Apnea Study will look at the brain health of people with severe sleep apnea both before and after 4 months of treatment with a CPAP machine. Pre- and post-CPAP treatment, 80 participants with severe sleep apnea will undergo cognitive testing, blood and urine tests, a pulse wave velocity test, and an MRI. Also pre- and post-CPAP treatment, participants will wear a blood pressure monitor for 24 hours, wear an accelerometer watch for 8 nights to track the duration and quality of their sleep, and wear a device for 1 night of sleep to assess their breathing and blood oxygen levels. It is expected that there will be improvements in participants' brain health after 4 months of CPAP treatment.
Detailed description
Between January 2018 and February 2022, the Brain Changes in Sleep Apnea Study will recruit 80 adults with newly diagnosed severe sleep apnea attending the sleep clinics at Sunnybrook Health Sciences Centre (n=40) or the University of Edinburgh (n=40). Participants will undergo home-based assessment with 3 wearable devices (24 hours of ambulatory blood pressure monitoring, 8 nights of actigraphy to assess sleep duration and fragmentation, and 1 night of finger-probe peripheral arterial tonometry and oximetry to assess cardiorespiratory physiology including sleep apnea), completion of a sleep and health questionnaire, 24-hour collection of urine for assessing sympathetic nervous system activity, blood banking for endothelial biomarkers, cognitive evaluation, pulse wave velocity test, and an MRI of the brain, at 2 time points: 1) after initial polysomnographic diagnosis of sleep apnea but before the initiation of CPAP, and 2) after 4 months of CPAP treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea patients | – | Diagnostic Test: Brain MRI, cognitive testing, bloodwork80 patients recently diagnosed with severe sleep apnea will participate in the Brain Changes in Sleep Apnea Study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 adults with newly diagnosed severe sleep apnea will be recruited from the sleep clinics at Sunnybrook Health Sciences Centre (n=40) or the University of Edinburgh (n=40).
Key inclusion criteria (5 listed)
- Newly diagnosed sleep apnea not on CPAP or any other treatment for sleep apnea;
- Apnea hypopnea index >=15 on diagnostic polysomnogram;
- Oxygen desaturation index >=10 or O2 saturation in sleep <90% for >15 minutes on diagnostic polysomnogram;
- Subjectively sleepy;
- Planning on starting CPAP for sleep apnea.
Key exclusion criteria (7 listed)
- Known history of stroke, transient ischemic attack, or other CNS disease;
- Unable to safely undergo MRI;
- Use of alpha-blocking agents;
- Persistent non-sinus arrhythmia;
- Severe pulmonary or cardiac diseases including COPD and CHF;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRI, cognitive testing, bloodworkParticipants will undergo 3-Tesla MRI. Scan time will be about 1 hour and 15 minutes per subject per session at the Sunnybrook site. The protocol is designed to image SVD burden by quantifying PVS and WMH volumes, and image various physiological estimates on the brain. Participants will undergo the following cognitive tests: Behavioural Neurology Assessment-R (BNA-R), Montreal Cognitive Assessment (MOCA), Center for Epidemiologic Studies Depression Scale (CES-D), and BrainScreen. Blood samples will be assayed for inflammatory and endothelial function. Classical vascular risk factors will also be assessed. Once data collection is complete, DNA will be extracted from the frozen PBMC fraction and will be genotyped for APOE genotype and a panel of other single nucleotide polymorphisms known to be associated with cognition and cerebrovascular disease. | Diagnostic test | Sleep apnea patients |
Primary outcome
Change from baseline in perivascular space volume
Time frame: Baseline and 4 months
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on perivascular space volume.
Change from baseline in DTI fractional anisotropy on voxel-wise basis
Time frame: Baseline and 4 months
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on DTI fractional anisotropy on voxel-wise basis.
Change from baseline in a summary measure of arterial pulsatility
Time frame: Baseline and 4 months
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on arterial pulsatility (as measured by the pulse wave velocity test).
Change from baseline in perivascular lactate measured by MR spectroscopy
Time frame: Baseline and 4 months
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on perivascular lactate (as measured by MR spectroscopy).
Change from baseline in cerebrovascular reactivity on a voxel-wise basis
Time frame: Baseline and 4 months
We will use repeated measures linear mixed effect models to estimate the main effect of CPAP (i.e. compare pre- and post-CPAP measurements) on cerebrovascular reactivity on a voxel-wise basis.
6 secondary outcomes
Change from baseline in 24-hour blood pressure
Time frame: Baseline and 4 months
Change from baseline in sleep duration and fragmentation
Time frame: Baseline and 4 months
Change from baseline in severity of sleep apnea, % deep NREM sleep, and hypoxemia
Time frame: Baseline and 4 months
Change from baseline in serum markers of metabolic, inflammatory, cardiovascular, and endothelial function
Time frame: Baseline and 4 months
Change from baseline in urinary measures of sympathetic nervous system
Time frame: Baseline and 4 months
Change from baseline in cognitive performance
Time frame: Baseline and 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Background: PubMed 8464434Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Background: PubMed 1798880Ancoli-Israel S, Kripke DF, Klauber MR, Mason WJ, Fell R, Kaplan O. Sleep-disordered breathing in community-dwelling elderly. Sleep. 1991 Dec;14(6):486-95. doi: 10.1093/sleep/14.6.486.
- Background: PubMed 21828324Yaffe K, Laffan AM, Harrison SL, Redline S, Spira AP, Ensrud KE, Ancoli-Israel S, Stone KL. Sleep-disordered breathing, hypoxia, and risk of mild cognitive impairment and dementia in older women. JAMA. 2011 Aug 10;306(6):613-9. doi: 10.1001/jama.2011.1115.
- Background: PubMed 20339144Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25.
- Background: PubMed 24136970Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.
- Background: PubMed 23633753Kim H, Yun CH, Thomas RJ, Lee SH, Seo HS, Cho ER, Lee SK, Yoon DW, Suh S, Shin C. Obstructive sleep apnea as a risk factor for cerebral white matter change in a middle-aged and older general population. Sleep. 2013 May 1;36(5):709-715B. doi: 10.5665/sleep.2632.
- Background: PubMed 26768207Lim AS, Yu L, Schneider JA, Bennett DA, Buchman AS. Sleep Fragmentation, Cerebral Arteriolosclerosis, and Brain Infarct Pathology in Community-Dwelling Older People. Stroke. 2016 Feb;47(2):516-8. doi: 10.1161/STROKEAHA.115.011608. Epub 2016 Jan 14.
- Background: PubMed 26163465Berezuk C, Ramirez J, Gao F, Scott CJ, Huroy M, Swartz RH, Murray BJ, Black SE, Boulos MI. Virchow-Robin Spaces: Correlations with Polysomnography-Derived Sleep Parameters. Sleep. 2015 Jun 1;38(6):853-8. doi: 10.5665/sleep.4726.
- Background: PubMed 23565003Malhotra A, Younes M, Kuna ST, Benca R, Kushida CA, Walsh J, Hanlon A, Staley B, Pack AI, Pien GW. Performance of an automated polysomnography scoring system versus computer-assisted manual scoring. Sleep. 2013 Apr 1;36(4):573-82. doi: 10.5665/sleep.2548.
- Background: PubMed 24918372Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.
- Background: PubMed 24327037Martinez-Garcia MA, Capote F, Campos-Rodriguez F, Lloberes P, Diaz de Atauri MJ, Somoza M, Masa JF, Gonzalez M, Sacristan L, Barbe F, Duran-Cantolla J, Aizpuru F, Manas E, Barreiro B, Mosteiro M, Cebrian JJ, de la Pena M, Garcia-Rio F, Maimo A, Zapater J, Hernandez C, Grau SanMarti N, Montserrat JM; Spanish Sleep Network. Effect of CPAP on blood pressure in patients with obstructive sleep apnea and resistant hypertension: the HIPARCO randomized clinical trial. JAMA. 2013 Dec 11;310(22):2407-15. doi: 10.1001/jama.2013.281250.
- Background: PubMed 26504189Hachinski V; World Stroke Organization. Stroke and Potentially Preventable Dementias Proclamation: Updated World Stroke Day Proclamation. Stroke. 2015 Nov;46(11):3039-40. doi: 10.1161/STROKEAHA.115.011237. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Lim, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Sleep Apnea, run by Dr. Andrew Lim 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Centen, MSc (416-480-5143, sleepapneabrain@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in perivascular space volume (time frame: Baseline and 4 months). The study lists 5 primary outcomes in all. 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 NCT03410095, which also lists 34 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 22 Mar 2021.