MedTrace Logo

CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea

NCT06089603 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive
  • Polycythemia

Interventions

DEVICE

Continuous positive airway pressure

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

DRUG

Conventional pharmacological treatment

Usual treatment of the patient

OTHER

Sleep ,diet and life style recomendations

Daily recomendatios

Sponsors & Collaborators

  • Hospital Universitario Ramon y Cajal

    lead OTHER

Principal Investigators

  • Aldara García-Sanchez, MD, phD · Hospital Ramon y Cajal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06089603 on ClinicalTrials.gov