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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
Sponsor:
Information provided by (Responsible Party):
Robert L. Owens, University of California, San Diego

Brief Summary:
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

Condition or disease
Human Immunodeficiency Virus Obstructive Sleep Apnea

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
PLWH+OSA
Subjects diagnosed with both Human Immunodeficiency Virus and Obstructive Sleep Apnea
PLWH-OSA
Subjects diagnosed with both Human Immunodeficiency Virus without Obstructive Sleep Apnea



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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
Approximately 10-15 cc of blood will be drawn in the morning at wake into serum separator and EDTA tubes. Serum samples will be immediately processed to separate serum, which will be stored in darkness at -70 F to preserve until analysis can be conducted. EDTA tubes will be processed and refrigerated for use within 24 hours. Blood will also be collected to measure high sensitivity C Reactive Protein (hsCRP), insulin, glucose (to calculate HOMA-IR), cytokines such as IL-6 and TNF-alpha.119 The investigators will also store plasma for other potential markers, to explore other interactions, such as markers of liver disease like ALT and AST.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People living with HIV on ART and demonstrated viral suppression will be recruited into the study to undergo a standard sleep study, a research sleep study, and other procedures designed to measure phenotypic expression of sleep/OSA. All of the planned experiments will take place at UCSD.

This study does not contain any exclusion by race, gender or ethnicity. We will only study subjects able to give self-consent. Thus, patients with existing severe dementia, children, prisoners, etc. will not be included. We believe that duration of HIV infection, HIV medication use and duration of use may be potentially important. However, while we will gather such information as completely as possible, we will not limit participation based on these factors. Finally, our preliminary data suggest that many PLWH use medications that might affect sleep, such as benzodiazepines, cannabinoids, etc. We plan to INCLUDE these subjects to increase the generalizability of our findings.

Criteria

Inclusion Criteria:

  • Physician diagnosis of HIV and viral suppression
  • Ages 18-65 years old
  • BMI 20 - 35 kg/m2

Exclusion Criteria:

  • Pregnancy
  • Inability to complete study procedures, such as questionnaires that are only available/validated in English.
  • Known OSA already on effective therapy and adherent to treatment
  • Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy. We will NOT exclude based on insomnia, given that OSA and insomnia frequently exist together.
  • Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease.

Information from the National Library of Medicine

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


Contacts
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Contact: Pam DeYoung, RPSGT 8582462183 pdeyoung@ucsd.edu
Contact: Robert Owens, MD 8586575258 rowens@ucsd.edu

Locations
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United States, California
Altman Clinical and Translational Research Institute Recruiting
San Diego, California, United States, 92093-0990
Contact: Pam Deyoung    858-246-2183      
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Robert Owens, MD UCSD Pulmonary and Sleep Medicine
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Responsible Party: Robert L. Owens, Associate Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03575143    
Other Study ID Numbers: 180160
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert L. Owens, University of California, San Diego:
HIV
OSA
PLWH
Sleep
Obstructive Sleep Apnea
Human Immunodeficiency Virus
CPAP
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Immunologic Deficiency Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases