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CPAP intervention for Obstructive Sleep Apnea

N/A
Waitlist Available
Led By Marie-Josée Brouillette, MD
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants in the cohort study "Understanding and Optimizing Brain Health in HIV Now"
Screened positive for OSA using the Berlin or the STOP-BANG (completed as part of the main study visits)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 months before the beginning of the intervention and up to 1 month after the end of the intervention.
Awards & highlights

Study Summary

Obstructive sleep apnea (OSA) is a breathing disorder that is characterized by episodes of complete or partial cessation of respiration during sleep, associated with upper airway collapse, oxygen desaturation and sleep fragmentation. OSA is a condition frequently implicated in cognitive disturbances, as well as associated with health conditions such as hypertension, metabolic disturbances and heightened risk of heart disease, stroke and mortality. These conditions are also increased in persons living with HIV. Individuals suffering from OSA report an increase in daytime sleepiness, mood changes and decline in quality of life.OSA also portends economic and societal impact through lost productivity at work and motor vehicle accidents. The presence of OSA is therefore important to detect in those living with HIV as it is potentially treatable contributors to cognitive disturbances in HIV. Continuous Positive Airway Pressure (CPAP) is the recommended treatment of choice for OSA. CPAP has established efficacy in improving cognition (executive function, long-term verbal and visual memory, attention/vigilance and global cognitive functioning). Although CPAP has been associated with improvements in cognitive functioning in the general population, its effectiveness in improving cognition in HIV+ individuals has never been previously tested. Given that cognitive disturbances in this population are multi-factorial, determining whether treatment of OSA in this population improves cognition is key in improving the clinical management of HIV+ individuals, both for its negative impact on cognition, but also more generally for their health.

Eligible Conditions
  • HIV (Human Immunodeficiency Virus)
  • Obstructive Sleep Apnea
  • Cognitive Impairment

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 months before the beginning of the intervention and up to 1 month after the end of the intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 months before the beginning of the intervention and up to 1 month after the end of the intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Cognitive Performance measure (B-CAM)
Secondary outcome measures
Adherence to the CPAP treatment
Changes Self-reported cognitive difficulties (C3Q)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: CPAP interventionExperimental Treatment1 Intervention
Over the course of 4-7 months, participants will have to wear the CPAP every night, at least 4 hours per night.
Group II: Control 1Active Control1 Intervention
Eligible participants who declined to participate in the study. Their main study visit data will be used to compare with the intervention group.
Group III: Control 2Active Control1 Intervention
Eligible participants who were not approached, hence not given the opportunity to accept or decline. Their main study visit data will be used to compare with the intervention group.

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Who is running the clinical trial?

McGill UniversityLead Sponsor
392 Previous Clinical Trials
984,579 Total Patients Enrolled
VitalAireIndustry Sponsor
4 Previous Clinical Trials
1,729 Total Patients Enrolled
ResMedIndustry Sponsor
135 Previous Clinical Trials
43,776 Total Patients Enrolled

Frequently Asked Questions

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~4 spots leftby Mar 2025