Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-02 @ 9:45 AM
Study NCT ID:
NCT03064204
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pathogenesis of OSA in People Living With HIV
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
The Pathogenesis of OSA in People Living With HIV
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: