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Metabolomics of Obstructive Sleep Apnea (MOSA)

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University of Pennsylvania

Status

Enrolling

Conditions

Obstructive Sleep Apnea

Treatments

Other: No Intervention

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

The primary objective of Aim 2 is to conduct a prospective observational study to evaluate the metabolomic changes in response to six months of positive airway pressure (PAP) treatment among OSA patients. Newly diagnosed OSA patients (AHI>5) will undergo additional measurements including: accelerometer x one week (to inform the metabolomics), Type 2 home sleep test (to assist with OSA subtyping), next morning blood draw, 24-hour diet recall (to inform the metabolomics), questionnaires and PVT.

Enrollment

1,000 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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).

Trial design

1,000 participants in 1 patient group

Subjects with OSA
Description:
Female and male subjects with Obstructive Sleep Apnea (OSA) (AHI \>5)
Treatment:
Other: No Intervention

Trial contacts and locations

2

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Central trial contact

Allan Pack, MBChB, PhD; Kristie C Nguyen

Data sourced from clinicaltrials.gov

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