The Brain Changes in Sleep Apnea Study
- Conditions
- Sleep Apnea SyndromesSleepSleep Apnea
- Interventions
- Diagnostic Test: Brain MRI, cognitive testing, bloodwork
- Registration Number
- NCT03410095
- Lead Sponsor
- Dr. Andrew Lim
- Brief 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sleep apnea patients Brain MRI, cognitive testing, bloodwork 80 patients recently diagnosed with severe sleep apnea will participate in the Brain Changes in Sleep Apnea Study.
- Primary Outcome Measures
Name Time Method Change from baseline in perivascular space volume 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Change from baseline in 24-hour blood pressure Baseline and 4 months We will quantify the main effect of CPAP treatment on 24-hour blood pressure (as measured by the ambulatory blood pressure monitor).
Change from baseline in sleep duration and fragmentation Baseline and 4 months We will quantify the main effect of CPAP treatment on sleep duration and fragmentation (as measured by the GENEActiv).
Change from baseline in severity of sleep apnea, % deep NREM sleep, and hypoxemia Baseline and 4 months We will quantify the main effect of CPAP treatment on severity of sleep apnea, % deep NREM sleep, and hypoxemia (as measured by the WatchPAT).
Change from baseline in serum markers of metabolic, inflammatory, cardiovascular, and endothelial function Baseline and 4 months We will quantify the main effect of CPAP treatment on serum markers of metabolic, inflammatory, cardiovascular, and endothelial function (as measured by blood tests).
Change from baseline in urinary measures of sympathetic nervous system Baseline and 4 months We will quantify the main effect of CPAP treatment on urinary measures of sympathetic nervous system (as measured with urine test).
Change from baseline in cognitive performance Baseline and 4 months 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).
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada