Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089603
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-09-26
Brief Title:
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Sponsor:
Hospital Universitario Ramon y Cajal
Organization:
Hospital Universitario Ramon y Cajal
Study Overview
Official Title:
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PoliAOS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None