Obstructive Sleep Apnea, CPAP Treatment & Cognitive Ability in HIV

NCT03478137 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-09-03

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

CPAP intervention

Participants who agree to participate will be evaluated by a sleep specialist who will confirm eligibility for CPAP treatment.Eligible participants will be referred to VitalAire for initiation of treatment following a standard protocol for CPAP use at home. CPAP treatment will continue until the next visit for the main study, between 4-7 months, based on the timing of the evaluations, after which the study will end.

Sponsors & Collaborators

  • VitalAire

    collaborator INDUSTRY
  • ResMed

    collaborator INDUSTRY
  • McGill University

    lead OTHER

Principal Investigators

  • Marie-Josée Brouillette, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Lesley K Fellows, MD/DPhil · McGill University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2021-09-13
Completion
2021-09-13

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478137 on ClinicalTrials.gov