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    • David Wallace BioDavid Wallace - MPN Patient Advocate

      David Wallace

      Founder & CEO of MPN Cancer Connection and PV Reporter | Patient Advocate

      When David was diagnosed with PV in 2009, at the age of 47, he soon learned there was limited and often conflicting information available on Myeloproliferative Neoplasms (MPNs). He also realized early on in his diagnosis, the importance of advocating for himself to best manage his polycythemia vera (PV). David was grateful for the early support and guidance of fellow MPN patients on his journey and wanted a way to give back to the MPN community. With a professional background in business administration and sociology, David has a passion for finding solutions and helping others. In 2013, David used his skill set to create PV Reporter,
      a comprehensive patient-focused website for MPNs. David refers to his site as a hub for patients to begin to research their cancer. Whether a patient, caregiver or healthcare provider, PV Reporter offers visitors a wealth of educational resources, patient stories, articles, and the latest news on the treatment for MPNs, helping MPN patients and their caregivers stay informed, connected and empowered. In 2015, along with the help of others, David founded a non-profit MPN Cancer Connection (MPN-CC), a patient-led 501©3 formed to create awareness that MPN patients are “cancer patients” and should have complete access to local and national programs and benefits. David’s philosophy is to educate patients to become their own advocates so that they can make informed decisions on their treatment. David’s dedication to the MPN community is further evidenced through his work and awards:
      • Selected to endorse 2018 NCCN guidelines for MPN patients by MPN Cancer Connection
      • Selected to represent the United States as a patient advocate by MPNs Advocate Network International Conference 2016-2019
      • Recipient of MPN Hero Award 2016
      • Published in MD Anderson Cancer Center MPN Focus Newsletter Fall 2016
      • Appearance on “The Doctors” TV show in 2015 to promote MPN awareness
      • Awarded Press Credentials for American Society of Hematology Conference 2014-2019
      • Contributor to Patient Power MPN educational videos
      David lives in Charlotte, North Carolina. When he’s not working, David enjoys spending time with family, listening to live music, attending outdoor festivals, watching the Carolina Panthers, riding his motorcycle, traveling and of course having his beloved Aussiedoodle Bailey by his side.
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Clinical Trial Finder

Clinical Trial Finder

Search Results

CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia

Study Purpose

This early phase I trial studies how well the use of a continuous positive airway pressure (CPAP) machine works in treating obstructive sleep apnea in patients with polycythemia vera or essential thrombocythemia. Obstructive sleep apnea is a condition where a person stops breathing during sleep, and is estimated to affect 30 to 50 percent of patients with polycythemia vera or essential thrombocythemia. A patient with obstructive sleep apnea typically snores, has disrupted sleep, experiences morning headaches, and has daytime sleepiness. Patients diagnosed with obstructive sleep apnea are typically treated with a device called CPAP. The CPAP provides pressurized air that keeps upper air passages open during sleep and may prevent them from narrowing or collapsing as occurs during snoring or sleep apnea.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - OSA SCREENING ELIGIBILITY CRITERIA: Documented diagnosis of essential thrombocythemia or polycythemia vera by either 2008 WHO criteria or 2016 WHO Criteria prior to screening.
  • - OSA SCREENING ELIGIBILITY CRITERIA: For subjects receiving therapy for PV or ET (i.e. hydroxyurea, peginterferon, etc.): Patients must be on a stable dose for >= 28 days prior to study entry and expected to remain on a stable dose for the duration of trial participation.
It is anticipated that during the 6 month duration of study, there will not be any dose modification of hydroxyurea or interferon and this will be communicated to treating providers and patient during enrollment into the trial. However, clinically indicated dose modification of PV/ET therapy while on trial will not necessitate CPAP study discontinuation.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Subject must have =< 20.0 pack-year smoking history OR have quit smoking => 3 years ago and do not have any current symptoms of COPD and/or have normal pulmonary function tests.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Negative serum or urine pregnancy test at screening for women of childbearing potential.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Highly effective contraception for both male and female subjects from study enrollment through treatment, and for at least 3 months after last study treatment administration if the risk of conception exists.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Able to read and complete required study questionnaires.
  • - TREATMENT ELIGIBILITY CRITERIA: Eligible for OSA Screening Component portion of this trial.
  • - TREATMENT ELIGIBILITY CRITERIA: Diagnosed OSA with Sleep Study score >= 5.
  • - TREATMENT ELIGIBILITY CRITERIA: Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference and Gender (STOP-BANG) screening questionnaire score >= 3.
  • - TREATMENT ELIGIBILITY CRITERIA: Willingness to comply with required CPAP compliance rate of >= 4hrs/day for 70% of days over 6 months of CPAP treatment.
  • - TREATMENT ELIGIBILITY CRITERIA: Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

  • - OSA SCREENING ELIGIBILITY CRITERIA: Use of JAK2 inhibitors within 6 months prior to registration.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Previous or current use of TNF inhibitors.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Prior substantial, prolonged use of CPAP or alternative therapy for OSA, including oxygen.
No more than 6 monthsof continuous therapy with CPAP in the last 5 years will be allowed.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Autoimmune disease requiring concurrent use of immunomodulatory, including rheumatologic disorders.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Prior invasive cancer (except nonmelanoma skin cancer) unless disease free for at least 2 years or life expectancy without treatment is greater than 2 years, e.g., low risk localized prostate cancer.
  • - OSA SCREENING ELIGIBILITY CRITERIA: The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: - Cardiovascular disorders: - Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
  • - Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
  • - Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months of screening.
Patients receiving anti-coagulant therapy for previous thromboembolic event will be allowed to enroll on study.
  • - Other clinically significant disorders that would preclude safe study participation.
  • - End stage Renal disease.
  • - Advanced liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • - Active (acute or chronic) or uncontrolled severe infection.
  • - OSA SCREENING ELIGIBILITY CRITERIA: Known history of human immunodeficiency virus (HIV), chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
  • - TREATMENT ELIGIBILITY CRITERIA: Use of JAK2 inhibitors within 6 months of registration.
  • - TREATMENT ELIGIBILITY CRITERIA: Previous or current use of TNF inhibitors.
  • - TREATMENT ELIGIBILITY CRITERIA: Prior use of CPAP or alternative therapy for OSA, including oxygen.
  • - TREATMENT ELIGIBILITY CRITERIA: Autoimmune disease requiring concurrent use of immunomodulatory, including rheumatologic disorders.
  • - TREATMENT ELIGIBILITY CRITERIA: Prior invasive cancer (except nonmelanoma skin cancer) unless disease free for at least 2 years or life expectancy without treatment is greater than 2 years, e.g., low risk localized prostate cancer.
  • - TREATMENT ELIGIBILITY CRITERIA: The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: - Cardiovascular disorders: - Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
  • - Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
  • - Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months of screening.
Patients receiving anti-coagulant therapy for previous thromboembolic event will be allowed to enroll on study.
  • - Other clinically significant disorders that would preclude safe study participation.
  • - End stage Renal disease.
  • - Advanced liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • - Active (acute or chronic) or uncontrolled severe infection.
  • - TREATMENT ELIGIBILITY CRITERIA: Known history of HIV, chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03972943
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Utah
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Krishna Sundar
Principal Investigator Affiliation Huntsman Cancer Institute/ University of Utah
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

CALR Gene Mutation, Essential Thrombocythemia, JAK2 Gene Mutation, MPL Gene Mutation, Obstructive Sleep Apnea Syndrome, Polycythemia Vera
Additional Details

PRIMARY OBJECTIVES:

  • I. To understand effects of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) on the course of polycythemia vera/essential thrombocythemia (PV/ET).
EXPLORATORY OBJECTIVES:
  • I. To estimate prevalence of OSA in patients with myeloproliferative neoplasms.
  • II. To understand effects of CPAP for sleep apnea on the course of myeloproliferative neoplasms (MPNs).
  • III. To correlate OSA severity with thrombotic and inflammatory marker values in patients with PV/ET at baseline.
OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I (OBSERVATIONAL COHORT): Patients not diagnosed with OSA undergo observation for 6 months. COHORT II (TREATMENT COHORT): Patients diagnosed with OSA and prescribed a CPAP machine for treatment receive continuous treatment with CPAP for 6 months.

Arms & Interventions

Arms

Active Comparator: Cohort I (observation)

Patients not diagnosed with OSA undergo observation for 6 months.

Experimental: Cohort II: (CPAP treatment)

Patients diagnosed with OSA and prescribed a CPAP machine for treatment receive continuous treatment with CPAP for 6 months.

Interventions

Procedure: - Continuous Positive Airway Pressure

Receive CPAP treatment

Other: - Patient Observation

Undergo observation

Other: - Questionnaire Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

Site Contact

Braxton Smith

Braxton.Smith@hci.utah.edu

801-213-8431

Veterans Administration Medical Center, Salt Lake City, Utah

Status

Recruiting

Address

Veterans Administration Medical Center

Salt Lake City, Utah, 84148

Site Contact

Michelle Westover

michelle.westover@va.gov

801-213-8431

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