The Brain Changes in Sleep Apnea Study

Sleep Clinical Trial

Official title:

The Brain Changes in Sleep Apnea Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03410095
• Other study ID #: SleepApneaStudy
• Status: Recruiting
• Start date: December 12, 2018
• Est. completion date: June 15, 2022

Study information

• Verified date: March 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: Andrew Centen, MSc
• Phone: 416-480-5143
• Email: sleepapneabrain[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Apnea
• Sleep
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Diagnostic Test:
• Brain MRI, cognitive testing, bloodwork
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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Andrew Lim	University of Edinburgh

Country where clinical trial is conducted

Canada, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 4 months
Primary	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.	Baseline and 4 months
Primary	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).	Baseline and 4 months
Primary	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).	Baseline and 4 months
Primary	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.	Baseline and 4 months
Secondary	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).	Baseline and 4 months
Secondary	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).	Baseline and 4 months
Secondary	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).	Baseline and 4 months
Secondary	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).	Baseline and 4 months
Secondary	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).	Baseline and 4 months
Secondary	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).	Baseline and 4 months