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NCT Number: NCT04572269

Metabolomics of Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iceland, Reykjavik, Iceland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Previously drawn laboratory Hemoglobin A1C above normal range (indicative of diabetes).

Treatment and study plan

No intervention

Other

This protocol does not involve an intervention of drug/device, diet, exercise or PAP compliance.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • University of Iceland

Registry information

Acronym: MOSA

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2020
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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