Condition or disease | Intervention/treatment | Phase |
---|---|---|
CALR Gene Mutation Essential Thrombocythemia JAK2 Gene Mutation MPL Gene Mutation Obstructive Sleep Apnea Syndrome Polycythemia Vera | Procedure: Continuous Positive Airway Pressure Other: Patient Observation Other: Questionnaire Administration | Early Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Modulation of Morbidity and Disease Progression in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Patients With Obstructive Sleep Apnea (OSA) by CPAP |
Actual Study Start Date : | May 15, 2019 |
Estimated Primary Completion Date : | May 1, 2024 |
Estimated Study Completion Date : | May 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Cohort I (observation)
Patients not diagnosed with OSA undergo observation for 6 months.
|
Other: Patient Observation
Undergo observation
Other Names:
Other: Questionnaire Administration Ancillary studies
|
Experimental: Cohort II: (CPAP treatment)
Patients diagnosed with OSA and prescribed a CPAP machine for treatment receive continuous treatment with CPAP for 6 months.
|
Procedure: Continuous Positive Airway Pressure
Receive CPAP treatment
Other Names:
Other: Questionnaire Administration Ancillary studies
|
Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
OSA SCREENING ELIGIBILITY CRITERIA: The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
Other clinically significant disorders that would preclude safe study participation.
TREATMENT ELIGIBILITY CRITERIA: The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
Other clinically significant disorders that would preclude safe study participation.
Contact: Braxton Smith | 801-213-8431 | Braxton.Smith@hci.utah.edu |
United States, Utah | |
Huntsman Cancer Institute/University of Utah | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
Contact: Braxton Smith 801-213-8431 Braxton.Smith@hci.utah.edu | |
Principal Investigator: Krishna Sundar |
Principal Investigator: | Krishna Sundar | Huntsman Cancer Institute/ University of Utah |
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 31, 2019 | ||||||
First Posted Date ICMJE | June 4, 2019 | ||||||
Last Update Posted Date | April 22, 2021 | ||||||
Actual Study Start Date ICMJE | May 15, 2019 | ||||||
Estimated Primary Completion Date | May 1, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures |
|
||||||
Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia | ||||||
Official Title ICMJE | Modulation of Morbidity and Disease Progression in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Patients With Obstructive Sleep Apnea (OSA) by CPAP | ||||||
Brief Summary | 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. | ||||||
Detailed Description |
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. |
||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Early Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE |
|
||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
72 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | May 2025 | ||||||
Estimated Primary Completion Date | May 1, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 30 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
|
||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03972943 | ||||||
Other Study ID Numbers ICMJE | HCI114917 NCI-2019-01690 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) HCI114917 ( Other Identifier: Huntsman Cancer Institute/University of Utah ) P30CA042014 ( U.S. NIH Grant/Contract ) |
||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Responsible Party | University of Utah | ||||||
Study Sponsor ICMJE | University of Utah | ||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||
Investigators ICMJE |
|
||||||
PRS Account | University of Utah | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |