Exploring metabolomics in patients with obstructive sleep apnea
Metabolomics of Obstructive Sleep Apnea
This study is testing if certain substances in the body can help us understand obstructive sleep apnea better and see how they change in people starting treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT04572269 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of metabolomics as a biomarker for obstructive sleep apnea (OSA). It utilizes previously collected samples from subjects with and without OSA and includes a prospective component where serum samples will be collected from newly diagnosed OSA patients undergoing positive airway pressure (PAP) treatment. Participants will undergo various assessments, including accelerometer monitoring, home sleep testing, and dietary recalls, to evaluate metabolomic changes over six months of treatment.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 30-75 who are in good general health and have been diagnosed with obstructive sleep apnea.
Not a fit: Patients currently using PAP treatment or those with active cancer treatment or heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment approaches for patients with obstructive sleep apnea based on metabolomic profiles.
How similar studies have performed: While the use of metabolomics in OSA is a relatively novel approach, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 30-75 years old 4. In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI\>5) 5. Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment. 6. 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: 1. Current use of PAP treatment or mandibular advancement device or INSPIRE device 2. Presence of active cancer treatment or heart failure (ejection fraction \<40%) 3. Pregnancy or lactation 4. Known allergic reactions to components of the plastic (used in PAP mask) 5. Febrile illness within 2 weeks of signing consent 6. Current drug or alcohol abuse 7. Known diagnosis and treatment of diabetes because this will independently alter metabolomic results. 8. Previously drawn laboratory Hemoglobin A1C above normal range (indicative of diabetes).
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Iceland — Reykjavík, Iceland (Recruiting)
Study contacts
- Principal investigator: Allan Pack, MBChB, PhD — University of Pennsylvania
- Study coordinator: Kristie C Nguyen
- Email: kristie.nguyen@pennmedicine.upenn.edu
- Phone: 215-615-4112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.