Metabolomics of Obstructive Sleep Apnea (NCT04572269) | Clinical Trial Compass
CompletedNot Applicable
Metabolomics of Obstructive Sleep Apnea
United States, Iceland388 participantsStarted 2020-09-29
Plain-language summary
This is an R01 funded project that focuses on the utility of metabolomics as a biomarker for OSA. Aims 1 and 3 leverages banked samples previously collected from subjects with and without OSA at the University of Pennsylvania and University of Iceland. Aim 2 is a prospective study that will collect serum samples from OSA subjects at the University of Pennsylvania and the University of Iceland.
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male or female, aged 30-75 years old
✓. In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI\>5)
✓. Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment.
✓. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
Exclusion criteria
✕. Current use of PAP treatment or mandibular advancement device or INSPIRE device
✕. Presence of active cancer treatment or heart failure (ejection fraction \<40%)
✕. Pregnancy or lactation
✕. Known allergic reactions to components of the plastic (used in PAP mask)
✕. Febrile illness within 2 weeks of signing consent
✕. Current drug or alcohol abuse
✕. Known diagnosis and treatment of diabetes because this will independently alter metabolomic results.
What they're measuring
1
Assess the utility of metabolomics to diagnose OSA and access whether these metabolomic signatures change with PAP treatment.
Timeframe: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4.