Obstructive Sleep ApneaNCT03064204
The Pathogenesis of OSA in People Living With HIV
An observational study of Obstructive Sleep Apnea and HIV/AIDS, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, HIV/AIDS
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2017to 4 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, HIV/AIDS
- Medical subject headings
- Sleep Apnea, Obstructive, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Upper airway collapsibility (Vpassive)
Upper airway collapsibility, as assessed by rapid withdrawal of PAP
Measured: Night 2 (Visit 2 - to occur within 6 weeks of enrollment)
Secondary outcomes (2)
Upper airway muscle responsiveness
As assessed by rapid withdrawal of PAP
Measured: Night 2 (Visit 2 - to occur within 6 weeks of enrollment)
Pharyngeal fat pad thickness
As measured by MRI of the head and neck
Measured: MRI study (Visit 3 - to occur within 6 weeks of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start9 Feb 2017
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Center For AIDS Research Creative and Novel Ideas in HIV Research (CFAR CNIHR)
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064204
- Sponsor's protocol ID
- UCSD 161299
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2017
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25150224Patil 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.
PubMed 24991815
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathogenesis of OSA in People Living With HIV
- ClinicalTrials.gov ID
- NCT03064204
- Acronym / sponsor ID
- UCSD 161299
- Conditions
- Obstructive Sleep Apnea, HIV/AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Center For AIDS Research Creative and Novel Ideas in HIV Research (CFAR CNIHR)
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper airway collapsibility (Vpassive)
Time frame: Night 2 (Visit 2 - to occur within 6 weeks of enrollment)
Upper airway collapsibility, as assessed by rapid withdrawal of PAP
2 secondary outcomes
Upper airway muscle responsiveness
Time frame: Night 2 (Visit 2 - to occur within 6 weeks of enrollment)
Pharyngeal fat pad thickness
Time frame: MRI study (Visit 3 - to occur within 6 weeks of enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 25150224Darquenne 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.
- Background: PubMed 24991815Patil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and HIV/AIDS, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper airway collapsibility (Vpassive) (time frame: Night 2 (Visit 2 - to occur within 6 weeks of enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064204, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.