RecruitingPhase 4NCT06089603

CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea


Sponsor

Hospital Universitario Ramon y Cajal

Enrollment

182 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Objectives: To compare the response of polycythemia in terms of hematocrit decrease in patients treated with positive airway pressure (CPAP) versus patients not treated with CPAP. Methodology: Randomized, parallel-group, nonblinded, controlled clinical trial. Patients diagnosed with OSA in a respiratory polygraphy (RP) and who meet all the inclusion criteria and none of the exclusion criteria will undergo sleepiness and quality of life questionnaires, anthropometric measurements and blood tests and will be randomized to a CPAP treatment group or control group, maintaining this treatment for 12 months. A visit will be made at 12 weeks ,24 weeks and 52 weeks to check compliance with CPAP in the treatment group and to carry out questionnaires on physical activity and quality of life, anthropometric measurements, blood tests including hemoglobin and hematocrit as well as parameters related to coagulation and platelet function and changes in medication as well as adverse effects. Efficacy variables: blood count, hemoglobin, haematocrit, erythropoietin, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), mean platelet volume (MPV), platelets, coagulation, erythrocyte range of distribution (ADE), glucose, creatinine, glomerular filtration rate, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), Total bilirubin, hypoxic burden, Epworth score, EuroQol- 5D questionnaire.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Continuous positive airway pressure, a drug called Conventional pharmacological treatment, and others for people with polycythemia and sleep apnea, obstructive. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous positive airway pressure

Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed)

DRUGConventional pharmacological treatment

Usual treatment of the patient

OTHERSleep ,diet and life style recomendations

Daily recomendatios


Locations(1)

Aldara García-Sanchez

Madrid, Madrid, Spain

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NCT06089603


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