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Metabolomics of Obstructive Sleep Apnea (MOSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04572269
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
University of Iceland
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Metabolomics of Obstructive Sleep Apnea
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : September 20, 2023
Estimated Study Completion Date : March 20, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
Serum, Plasma, Platelet Poor Plasma (PPP), Peripheral Blood Monocyte Cell (PBMC) and anticoagulated whole blood,


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Prospective recruitment of female and male OSA subjects n=250/site: Site #1 is University of Pennsylvania; Site #2 is University of Iceland for a total of n=500 cases.
Criteria

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 18-90 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572269


Contacts
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Contact: Kristie Nguyen 215-615-4112 kristie.nguyen@pennmedicine.upenn.edu
Contact: Allan Pack, MBChB, PhD 215-746-4801 pack@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristie Nguyen    215-615-4112    kristie.nguyen@pennmedicine.upenn.edu   
Contact: Fran Pack    215-614-1807    Fran.Pack@pennmedicine.upenn.edu   
Principal Investigator: Diane C Lim, MD, MTR         
Iceland
University of Iceland Not yet recruiting
Reykjavík, Iceland, 108
Contact: Thorarinn Gislason, MD, PhD    354-824-5727    thorarig@landspitali.is   
Contact: Bryndís Benediktsdóttir, MD    354-543-1000    brynben@hi.is   
Principal Investigator: Thorarinn Gislason, MD, PhD         
Principal Investigator: Bryndís Benediktsdóttir, MD         
Sponsors and Collaborators
University of Pennsylvania
University of Iceland
Investigators
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Study Director: Diane C Lim, MD, MTR University of Pennsylvania
Principal Investigator: Aalim Weljie, PhD University of Pennsylvania
Publications:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04572269    
Other Study ID Numbers: 835027
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored in REDcap. This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by clinical sites and by the University of Pennsylvania research staff will be secured and password protected. At the end of the study, all study databases will be de-identified and archived at figshare <https://figshare.com>.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: IPD will be available to research teams within 1 year following study completion.
Access Criteria: Data collected for this study will be analyzed and stored in figshare <https://figshare.com>. After the study is completed, the de-identified, archived data will be transmitted to and stored in figshare <https://figshare.com>, for use by other researchers including those outside of the study.
URL: http://figshare.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Metabolomics
Biomarker
PAP
OSA Subtype
Personalized medicine
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases