MOSA: Metabolomics of Obstructive Sleep Apnea

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT04572269

Collaborator

University of Iceland (Other)

1,000

Enrollment

Locations

41.9

Anticipated Duration (Months)

500

Patients Per Site

11.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Other: No Intervention

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Metabolomics of Obstructive Sleep Apnea

Actual Study Start Date :

Sep 21, 2020

Anticipated Primary Completion Date :

Sep 20, 2023

Anticipated Study Completion Date :

Mar 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Subjects with OSA Female and male subjects with Obstructive Sleep Apnea (OSA) (AHI >5)	Other: No Intervention This protocol does not involve an intervention of drug/device, diet, exercise or PAP compliance.

Arm

Intervention/Treatment

Subjects with OSA

Female and male subjects with Obstructive Sleep Apnea (OSA) (AHI >5)

Other: No Intervention

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

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Evaluate whether the metabolomic response to PAP treatment is modified by degree of obesity. [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.
Examine whether OSA symptom subtypes have a different metabolomic responses to PAP treatment. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).