Recruiting

Observational Study

Sponsor:

Dr. Andrew Lim

Code:

NCT03410095

Conditions

Sleep

Sleep Apnea

Sleep Apnea Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain MRI, cognitive testing, bloodwork

Study Details

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.

Conditions

Sleep

Sleep Apnea

Sleep Apnea Syndromes

Study ID

NCT03410095

Start date

Dec 12, 2018

Status verified date

Mar, 2021

Completion date

Jun 15, 2022

Anticipated

Primary completion date

Feb 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Sleep apnea patients

80 patients recently diagnosed with severe sleep apnea will participate in the Brain Changes in Sleep Apnea Study.

Interventions

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.

Primary outcome measure

  • Change from baseline in perivascular space volume [ Time Frame: Baseline and 4 months ]
  • Change from baseline in DTI fractional anisotropy on voxel-wise basis [ Time Frame: Baseline and 4 months ]
  • Change from baseline in a summary measure of arterial pulsatility [ Time Frame: Baseline and 4 months ]
  • Change from baseline in perivascular lactate measured by MR spectroscopy [ Time Frame: Baseline and 4 months ]
  • Change from baseline in cerebrovascular reactivity on a voxel-wise basis [ Time Frame: Baseline and 4 months ]

Central Contacts and Locations

Central contacts

Andrew Centen, MSc

416-480-5143sleepapneabrain@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Andrew Centen, MSc

416-480-5143sleepapneabrain@sunnybrook.ca

More Information

Sponsor

Dr. Andrew Lim

Last update posted

Mar 22, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Andrew Lim on 2021-03-22.