Obstructive Sleep Apnea Clinical Trial
Official title:
The Pathogenesis of OSA in People Living With HIV
Verified date | February 2022 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | November 4, 2020 |
Est. primary completion date | November 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Center For AIDS Research Creative and Novel Ideas in HIV Research (CFAR CNIHR) |
United States,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Upper airway muscle responsiveness | As assessed by rapid withdrawal of PAP | Night 2 (Visit 2 - to occur within 6 weeks of enrollment) | |
Secondary | Pharyngeal fat pad thickness | As measured by MRI of the head and neck | MRI study (Visit 3 - to occur within 6 weeks of enrollment) |
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