Metabolomics of Obstructive Sleep Apnea

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: No Intervention

• Registration Number: NCT04572269
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-25
• Study Start: 2020-09-29
• Study First Posted: 2020-10-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assess the utility of metabolomics to diagnose OSA and access whether these metabolomic signatures change with PAP treatment.	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (2)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Iceland; 🇮🇸 Reykjavík, Iceland