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Metabolomics of Obstructive Sleep Apnea

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Conditions

Obstructive Sleep ApneaMetabolomicsBiomarkerPAPOSA SubtypePersonalized medicine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Metabolomics of Obstructive Sleep Apnea

Quick Facts

Study Start:2020-09-29
Study Completion:2025-09-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04572269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female, aged 30-75 years old
  4. 4. In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI\>5)
  5. 5. Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment.
  6. 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.
  1. 1. Current use of PAP treatment or mandibular advancement device or INSPIRE device
  2. 2. Presence of active cancer treatment or heart failure (ejection fraction \<40%)
  3. 3. Pregnancy or lactation
  4. 4. Known allergic reactions to components of the plastic (used in PAP mask)
  5. 5. Febrile illness within 2 weeks of signing consent
  6. 6. Current drug or alcohol abuse
  7. 7. Known diagnosis and treatment of diabetes because this will independently alter metabolomic results.
  8. 8. Previously drawn laboratory Hemoglobin A1C above normal range (indicative of diabetes).

Contacts and Locations

Principal Investigator

Allan Pack, MBChB, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Aalim Weljie, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Allan Pack, MBChB, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Aalim Weljie, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-29
Study Completion Date2025-09-12

Study Record Updates

Study Start Date2020-09-29
Study Completion Date2025-09-12

Terms related to this study

Keywords Provided by Researchers

  • Metabolomics
  • Biomarker
  • PAP
  • OSA Subtype
  • Personalized medicine

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea