CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug, Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Subjects from 18 to 80 years old.

• Diagnosis of polycytemia defined as hematocrit \> 49% in men and \> 48% in women. ç

• Diagnosis of moderate or severe sleep apnea, defined by an apnea-hypoapnea index \>15. - Patients able to read and understand informed consent and give their signed consent.

Locations
Other Locations
Spain
Aldara García-Sanchez
RECRUITING
Madrid
Contact Information
Primary
Aldara García-Sanchez, MD, phD
aldara.garcia.ag@gmail.com
+34686810368
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 182
Treatments
Experimental: CPAP treatment
Diet and conventional pharmacological treatment plus continuous positive airway pressure (CPAP)
Active_comparator: Control treatment
Diet and conventional pharmacological treatment
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitario Ramon y Cajal

This content was sourced from clinicaltrials.gov