The Pathogenesis of OSA in People Living With HIV

The purpose of this study is to help us understand how HIV and/or Anti-Retroviral Therapy (ART) may predispose individuals to Obstructive Sleep Apnea (OSA). The traditional risk factors for OSA are weight and age. However, people living with HIV on ART seem to have OSA even when they are thin and young. The study involves a detailed physiological sleep study and an MRI of the head and neck to understand the underlying cause of OSA in those with and without HIV.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Obstructive Sleep Apnea

Detailed Description

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
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women with physician-diagnosed OSA who have been prescribed and are using positive airway pressure (e.g. CPAP). Also, men and women with physician-diagnosed HIV who achieved viral suppresion.

Description

Inclusion Criteria:

• Men and women with physician-diagnosed OSA who have been prescribed CPAP Ages >= 40 years old
• BMI 20 - 35 kg/m2
• For HIV group: physician diagnosis of HIV and viral suppression

Exclusion Criteria:

• Not compliant with CPAP (by Medicare criteria, e.g. ≥4 hours per night on 70% of nights during a consecutive 30-day period via direct download or visual inspection of usage data).
• Use of medication that affects the traits, e.g. narcotics or sedative-hypnotics
• Any cardiovascular, pulmonary or renal disease other than well controlled hypertension or asthma.
• Pregnancy
• Currently smoking
• Any respiratory disorder other than OSA or well controlled asthma
• contraindication to MRI

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
OSA+CPAP+HIV+; Individuals (40 years or older) diagnosed with OSA and using CPAP, also with HIV treated to viral suppression.
OSA+CPAP+HIV-; Individuals (40 years or older) diagnosed with OSA and using CPAP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper airway collapsibility (Vpassive)	Upper airway collapsibility, as assessed by rapid withdrawal of PAP	Night 2 (Visit 2 - to occur within 6 weeks of enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper airway muscle responsiveness	As assessed by rapid withdrawal of PAP	Night 2 (Visit 2 - to occur within 6 weeks of enrollment)
Pharyngeal fat pad thickness	As measured by MRI of the head and neck	MRI study (Visit 3 - to occur within 6 weeks of enrollment)

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Center For AIDS Research Creative and Novel Ideas in HIV Research (CFAR CNIHR)

Publications and helpful links

General Publications

• Darquenne C, Hicks CB, Malhotra A. The ongoing need for good physiological investigation: obstructive sleep apnea in HIV patients as a paradigm. J Appl Physiol (1985). 2015 Jan 15;118(2):244-6. doi: 10.1152/japplphysiol.00656.2014. Epub 2014 Aug 21. No abstract available.
• Patil SP, Brown TT, Jacobson LP, Margolick JB, Laffan A, Johnson-Hill L, Godfrey R, Johnson J, Reynolds S, Schwartz AR, Smith PL. Sleep disordered breathing, fatigue, and sleepiness in HIV-infected and -uninfected men. PLoS One. 2014 Jul 3;9(7):e99258. doi: 10.1371/journal.pone.0099258. eCollection 2014.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2017
• Primary Completion (Actual): November 4, 2020
• Study Completion (Actual): November 4, 2020

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: UCSD 161299

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No