Clinical trial NCT03064204: The Pathogenesis of OSA in People Living With HIV
Official title: The Pathogenesis of OSA in People Living With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
HIV/AIDS
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Center For AIDS Research Creative and Novel Ideas in HIV Research (CFAR CNIHR)
First posted: 2017-02-24
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Upper airway collapsibility (Vpassive)
timeFrame: Night 2 (Visit 2 - to occur within 6 weeks of enrollment)
Secondary outcomes:
measure: Upper airway muscle responsiveness
timeFrame: Night 2 (Visit 2 - to occur within 6 weeks of enrollment)
measure: Pharyngeal fat pad thickness
timeFrame: MRI study (Visit 3 - to occur within 6 weeks of enrollment)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: 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.
citation: 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.