Metabolomics of Obstructive Sleep Apnea (MOSA)
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|ClinicalTrials.gov Identifier: NCT04572269|
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Other: No Intervention|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Metabolomics of Obstructive Sleep Apnea|
|Actual Study Start Date :||September 21, 2020|
|Estimated Primary Completion Date :||September 20, 2023|
|Estimated Study Completion Date :||March 20, 2024|
Subjects with OSA
Female and male subjects with Obstructive Sleep Apnea (OSA) (AHI >5)
Other: No Intervention
This protocol does not involve an intervention of drug/device, diet, exercise or PAP compliance.
- Assess the utility of metabolomics to diagnose OSA and access whether these metabolomic signatures change with PAP treatment. [ Time Frame: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4. ]New OSA patients, AHI>5 will be recruited. Since this is a real-world trial, compliance of PAP usage will vary from 0 to 100%. Thus, we will be able to assess not only what metabolomic changes occur with PAP usage but also whether there is a correlation to the amount of PAP usage. Metabolomics can be used as a biomarker that correlates with duration and frequency of PAP usage. This will then be correlated to subjective and objective measures of daytime sleepiness (questionnaires + PVT) and sleep fragmentation.
- Determine a metabolic signature that correlates with duration and frequency of PAP usage. This will then be correlated to subjective and objective measures of daytime sleepiness and sleep fragmentation. [ Time Frame: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4. ]We will assess whether there is a specific metabolic signature that strongly associates with PAP adherence, potentially independent of the metabolites in Outcome 1. Identifying the set of metabolites with the strongest association with PAP usage will allow us to define an objective biomarker for quantifying PAP adherence. Moreover, the pathways implicated by these biomarkers are likely to allude to certain mechanisms of response.
- Evaluate whether the metabolomic response to PAP treatment is modified by degree of obesity. [ Time Frame: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4. ]We will utilize conditional MSMs that estimate whether the effect of PAP varies with BMI.
- Examine whether OSA symptom subtypes have a different metabolomic responses to PAP treatment. [ Time Frame: We anticipate prospective recruitment to be completed within 3.5 years with final analyses completed by year 4. ]We will utilize conditional MSMs that estimate whether the effect of PAP varies across symptom subtypes.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572269
|Contact: Kristie Nguyenemail@example.com|
|Contact: Allan Pack, MBChB, PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Kristie Nguyen 215-615-4112 email@example.com|
|Contact: Fran Pack 215-614-1807 Fran.Pack@pennmedicine.upenn.edu|
|Principal Investigator: Diane C Lim, MD, MTR|
|University of Iceland||Not yet recruiting|
|Reykjavík, Iceland, 108|
|Contact: Thorarinn Gislason, MD, PhD 354-824-5727 firstname.lastname@example.org|
|Contact: Bryndís Benediktsdóttir, MD 354-543-1000 email@example.com|
|Principal Investigator: Thorarinn Gislason, MD, PhD|
|Principal Investigator: Bryndís Benediktsdóttir, MD|
|Study Director:||Diane C Lim, MD, MTR||University of Pennsylvania|
|Principal Investigator:||Aalim Weljie, PhD||University of Pennsylvania|