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NCT03575143: PLWH/OSA

Obstructive Sleep Apnea Endotypes and Impact on Phenotypes of People Living With HIV

Completed Results posted Last updated 21 August 2023
What this trial tests

trial in Human Immunodeficiency Virus in 132 participants. Completed in 16 July 2022.

Timeline
2 August 2018
Primary endpoint
14 July 2022
16 July 2022

Quick facts

Lead sponsorUniversity of California, San Diego
StatusCompleted
Study typeOBSERVATIONAL
Enrollment132
Start date2 August 2018
Primary completion14 July 2022
Estimated completion16 July 2022
Sites1 location across United States

Conditions studied

Sponsor

University of California, San Diego

Who can join

Adults 18 to 65, any sex, with Human Immunodeficiency Virus or Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reaction Time Measured Using the Psychomotor Vigilance Task Primary · 1 day

The Psychomotor Vigilance Task (PVT) is commonly used to asses the impact of sleep (or sleep deprivation) on cognitive performance. Subjects are instructed to respond (by tapping a key on a keyboard) as fast as possible to a graphical stimulus displayed on a computer screen. The stimulus is presented multiple times at variable intervals every few seconds for 10 minutes. The reaction time is the mean latency from appearance of the stimulus to the response by the participant. Higher values suggest a slower reaction time compared to lower values.

GroupValue95% CI
PLWH+OSA+High AT346± 38
PLWH+OSA+Low AT353± 39
PLWH-OSA348± 48
Reactive Hyperemia Index (RHI) Assessed by Peripheral Arterial Tonometry Secondary · 1 day

Reactive hyperemia is measured using the commercially available EndoPAT device (Itamar Medical). Briefly, the device uses finger plethysmography to measure the finger arterial pulse wave amplitude. Subjects have the pulse wave measured during rest, during the application of a blood pressure cuff to occlude blood flow for 5 minutes, and then once the blood pressure cuff is deflated. The reactive hyperemia index (RHI) is the ratio (thus dimensionless) of the pulse wave amplitude after occlusion compared to the pre-occlusion value. Values for the RHI are physiologically greater than 1 (least heal

GroupValue95% CI
PLWH+OSA+Low LG1.6± .38
PLWH+OSA+High LG1.52± .36

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of participation in the study, which varied according to each study participant. Those subjects who were PLWH-OSA completed the study generally in 7-10 days. Subjects who were PLWH+OSA completed an additional overnight sleep study and then used CPAP therapy for 12 weeks. Their participation in the study might be up to 6 months depending on the timing of procedures.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PLWH+OSA
Serious: 0/66 (0%)
Deaths: 0/66
PLWH-OSA
Serious: 0/55 (0%)
Deaths: 0/55
PLWH?OSA
Serious: 0/11 (0%)
Deaths: 0/11
Other adverse events (1 terms — click to expand)

ReactionSystemPLWH+OSAPLWH-OSAPLWH?OSA
EpistaxisSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT03575143 adverse events section.

Sponsor's own description

The investigators seek to understand how the different underlying causes of OSA affect the way people living with HIV (PLWH) experience OSA. The investigators also want to understand how symptoms of obstructive sleep apnea improve with treatment, and if this too, is affected by the underlying cause of OSA in that individual

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pathogenesis of obstructive sleep apnea in people living with HIV.
    Orr JE, Edwards BA, Schmickl CN, Karris M, et al · · 2021 · cited 8× · PMID 34672765 · DOI 10.1152/japplphysiol.00591.2021
  2. Sleep, Sleep Apnea, and Fatigue in People Living With HIV.
    Orr JE, Velazquez J, Schmickl CN, Bosompra NO, et al · · 2024 · cited 2× · PMID 39250653 · DOI 10.1097/qai.0000000000003481
  3. Diagnostic performance of screening tools for the detection of obstructive sleep apnea in people living with HIV.
    Schmickl CN, Bosompra NO, DeYoung PN, Gilbertson D, et al · · 2022 · cited 1× · PMID 35383569 · DOI 10.5664/jcsm.9964
  4. Effects of Treating Obstructive Sleep Apnea on Common Symptoms of HIV.
    Berry DL, Orr JE, Schmickl CN, DeYoung P, et al · · 2025 · PMID 40856602 · DOI 10.1097/qai.0000000000003753

Verify or expand the search:

Other recruiting trials for Human Immunodeficiency Virus

Currently open trials in the same condition.

Other University of California, San Diego trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03575143.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing