NCT03113461

MCI: CPAP Treatment of OSA (Memories2)

Changing the Trajectory of Mild Cognitive Impairment With CPAP Treatment of Obstructive Sleep Apnea

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this project is to determine whether obstructive sleep apnea (OSA) treatment with positive airway pressure therapy (CPAP) can delay the progression of cognitive impairment in patients with amnestic Mild Cognitive Impairment (MCI) as measured by cognitive testing, and brain magnetic resonance imaging (MRI) scans. Study participants will be assessed at baseline, six-month (cognitive tests only) and one-year follow-up.

Detailed description

A growing number of research studies suggest that obstructive sleep apnea (OSA), characterized by episodic nocturnal collapse of the upper airway and reduction/cessation of breathing leading to significant nocturnal hypoxia, is associated with an increased risk of cognitive impairment. OSA is effectively treated with continuous positive airway pressure (CPAP), a pressurized nasal/face mask worn during sleep, but health care providers do not often prescribe it for Mild Cognitive Impairment (MCI) because there are no large, prospective research studies in this population confirming efficacy. This multi-site study will have a sample size of n=460 divided into three groups followed for one year: 1) a CPAP adherent group (approximately n=200); 2) two control groups consisting of 2a) a CPAP non-adherent control group (approximately n=160) and 2b) a no apnea control group (n=100). This will allow us to confirm whether CPAP treatment, controlling for risk factors such as neuroimaging findings and OSA severity at baseline, predicts the primary outcome of cognitive function at 1-year follow-up. Study participants will also undergo an Amyloid PET scan, use wearable activity monitors and functional/structural MRI brain scans. This research study will thus examine the one year effects of CPAP on cognitive function and elucidate physiological mechanisms for cognitive decline in aMCI and OSA.

Conditions

• Mild Cognitive Impairment
• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	CPAP	non-invasive positive airway pressure applied using an oronasal mask

Timeline

• Start date: 2018-01-19
• Primary completion: 2023-01-31
• Completion: 2025-07-01
• First posted: 2017-04-13
• Last updated: 2023-04-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study