The Pathogenesis of OSA in People Living With HIV
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|ClinicalTrials.gov Identifier: NCT03064204|
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : April 16, 2019
|Condition or disease|
|Obstructive Sleep Apnea HIV/AIDS|
Participants who have sleep apnea and are using positive airway pressure (PAP) with and without HIV will be enrolled if they otherwise meet all the inclusion criteria, and none of the exclusion criteria.
Subjects will undergo two overnight sleep studies (polysomnograms, PSGs) and a MRI scan of the upper airway. The first sleep study will evaluate the severity of sleep disordered breathing and will be identical to a clinical PSG. The second sleep study will measure the physiological traits most important for OSA, such as upper airway anatomy, control of breathing, sleep stability, and upper airway muscle activation. These measurements are performed while subjects sleep using PAP, but the PAP level is adjusted during the night, and the subject's response is measured. The MRI scan will be of the head and neck and will occur during the evening time. Subjects will be encouraged to sleep during this portion of the study, as well.
|Study Type :||Observational|
|Estimated Enrollment :||44 participants|
|Official Title:||The Pathogenesis of OSA in People Living With HIV|
|Actual Study Start Date :||February 9, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Individuals (40 years or older) diagnosed with OSA and using CPAP, also with HIV treated to viral suppression.
Individuals (40 years or older) diagnosed with OSA and using CPAP.
- Upper airway collapsibility (Vpassive) [ Time Frame: Night 2 (Visit 2 - to occur within 6 weeks of enrollment) ]Upper airway collapsibility, as assessed by rapid withdrawal of PAP
- Upper airway muscle responsiveness [ Time Frame: Night 2 (Visit 2 - to occur within 6 weeks of enrollment) ]As assessed by rapid withdrawal of PAP
- Pharyngeal fat pad thickness [ Time Frame: MRI study (Visit 3 - to occur within 6 weeks of enrollment) ]As measured by MRI of the head and neck
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): NCT03064204
|Contact: Robert L Owens, M.D.||(858) email@example.com|
|Contact: Pamela DeYoung, RPSGTfirstname.lastname@example.org|
|United States, California|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92093|
|Contact: Robert L Owens, MD 858-657-5258 email@example.com|
|Principal Investigator: Robert L Owens, MD|