The Brain Changes in Sleep Apnea Study

March 17, 2021 updated by: Dr. Andrew Lim
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sleep apnea patients
80 patients recently diagnosed with severe sleep apnea will participate in the Brain Changes in Sleep Apnea Study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 months
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.
Baseline and 4 months
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).
Baseline and 4 months
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).
Baseline and 4 months
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.
Baseline and 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in 24-hour blood pressure
Time Frame: 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).
Baseline and 4 months
Change from baseline in sleep duration and fragmentation
Time Frame: Baseline and 4 months
We will quantify the main effect of CPAP treatment on sleep duration and fragmentation (as measured by the GENEActiv).
Baseline and 4 months
Change from baseline in severity of sleep apnea, % deep NREM sleep, and hypoxemia
Time Frame: 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).
Baseline and 4 months
Change from baseline in serum markers of metabolic, inflammatory, cardiovascular, and endothelial function
Time Frame: 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).
Baseline and 4 months
Change from baseline in urinary measures of sympathetic nervous system
Time Frame: 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).
Baseline and 4 months
Change from baseline in cognitive performance
Time Frame: 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).
Baseline and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Andrew Lim

Collaborators

University of Edinburgh

Investigators

  • Principal Investigator: Andrew Lim, MD, FRCPC, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Anticipated)

February 15, 2022

Study Completion (Anticipated)

June 15, 2022

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SleepApneaStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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