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Trial record 2 of 237743 for:    ALL

The Pathogenesis of OSA in People Living With HIV

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by University of California, San Diego
Sponsor:
Collaborator:
Center For AIDS Research Creative and Novel Ideas in HIV Research (CFAR CNIHR)
Information provided by (Responsible Party):
Robert L. Owens, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT03064204
First received: February 17, 2017
Last updated: February 21, 2017
Last verified: February 2017
  Purpose
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.

Condition
Obstructive Sleep Apnea
HIV/AIDS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pathogenesis of OSA in People Living With HIV

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Upper airway muscle responsiveness [ Time Frame: Night 2 (Visit 2 - to occur within 6 weeks of enrollment) ]
    As assessed by rapid withdrawal of PAP

  • Pharyngeal fat pad thickness [ Time Frame: MRI study (Visit 3 - to occur within 6 weeks of enrollment) ]
    As measured by MRI of the head and neck


Estimated Enrollment: 44
Anticipated Study Start Date: February 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   40 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03064204

Contacts
Contact: Robert L Owens, M.D. (858) 657-5258 rowens@ucsd.edu
Contact: Pamela DeYoung, RPSGT 858-2432-0343 pdeyoung@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Robert L Owens, MD    858-657-5258    rowens@ucsd.edu   
Principal Investigator: Robert L Owens, MD         
Sponsors and Collaborators
University of California, San Diego
Center For AIDS Research Creative and Novel Ideas in HIV Research (CFAR CNIHR)
  More Information

Publications:
Responsible Party: Robert L. Owens, Associate Physician, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03064204     History of Changes
Other Study ID Numbers: UCSD 161299 
Study First Received: February 17, 2017
Last Updated: February 21, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 24, 2017