Obstructive Sleep Apnea Endotypes and Impact on Phenotypes of People Living With HIV (PLWH/OSA)
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|ClinicalTrials.gov Identifier: NCT03575143|
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : January 7, 2021
|Condition or disease|
|Human Immunodeficiency Virus Obstructive Sleep Apnea|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Obstructive Sleep Apnea Endotypes and Impact on Phenotypes of People Living With HIV|
|Actual Study Start Date :||August 2, 2018|
|Estimated Primary Completion Date :||July 15, 2022|
|Estimated Study Completion Date :||July 15, 2022|
Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea
Subjects diagnosed with both Human Immunodeficiency Virus without Obstructive Sleep Apnea
- Neurocognitive Performance [ Time Frame: 1 day ]Compare neurocognitive performance [psychomotor vigilance test (primary outcome), NIH Toolbox Cognition] in PLWH+OSA with low arousal threshold vs. those with a high arousal threshold. The investigators hypothesize that stratified for similar disease severity, low arousal threshold induced OSA yields worse neurocognitive dysfunction compared to equal severity OSA with high arousal threshold.
- Endothelial Function [ Time Frame: 1 day ]Compare endothelial function (arterial tonometry) in PLWH+OSA with high loop gain (ventilatory instability with associated hypoxemia/hypercapnia) vs. those with low LG, to test the hypothesis that stratified for similar disease severity, LG-induced OSA yields worse endothelial function compared to equal severity OSA with low LG.
- OSA Manifestations [ Time Frame: 3 months ]To test in PLWH+OSA whether 3 months of PAP treatment results in changes in OSA manifestations. This aim will allow us to test the hypothesis that endotype underlying OSA will be predictive of the specific clinical improvements seen in adherent users of PAP therapy. For example, those with high LG at baseline will have the greatest improvement in endothelial dysfunction with PAP therapy compared to other OSA patients with similar disease severity as measured by AHI.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575143
|Contact: Pam DeYoung, RPSGTfirstname.lastname@example.org|
|Contact: Robert Owens, MDemail@example.com|
|United States, California|
|Altman Clinical and Translational Research Institute||Recruiting|
|San Diego, California, United States, 92093-0990|
|Contact: Pam Deyoung 858-246-2183|
|Principal Investigator:||Robert Owens, MD||UCSD Pulmonary and Sleep Medicine|