NCT03972943

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

Modulation of Morbidity and Disease Progression in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Patients With Obstructive Sleep Apnea (OSA) by CPAP

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CALR Gene Mutation
• Essential Thrombocythemia
• JAK2 Gene Mutation
• MPL Gene Mutation
• Obstructive Sleep Apnea Syndrome
• Polycythemia Vera

Interventions

Type	Name	Description
PROCEDURE	Continuous Positive Airway Pressure	Receive CPAP treatment
OTHER	Patient Observation	Undergo observation
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-05-15
• Primary completion: 2023-07-28
• Completion: 2023-07-28
• First posted: 2019-06-04
• Last updated: 2024-01-08

Locations

2 sites across 1 country: United States