The Pathogenesis of OSA in People Living With HIV

Obstructive Sleep Apnea Clinical Trial

Official title:

The Pathogenesis of OSA in People Living With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064204
• Other study ID #: UCSD 161299
• Status: Completed
• Start date: February 9, 2017
• Est. completion date: November 4, 2020

Study information

• Verified date: February 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• HIV/AIDS
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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)