CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital Universitario Ramon y Cajal
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Smokers or former smokers with pack-year index (IPA>30) or chronic obstructive pulmonary disease diagnosed by spirometry (FEV1/FVC post-bronchodilator below the lower limit of normal or z score < 1.645).
Patients with central sleep apnea or periodic breathing
Patients with oxygen saturation <92% or pO2< 60 mmHg at rest during wakefulness. - Evidence of severe heart failure (LVEF<50) or pulmonary hypertension.
Patients with primary polyglobulia (polycythemia vera). It will be done prior to the inclusion in the study blood levels of erythropoietin (EPO) and determination of the mutation of the JAK2 V617F gene. Patients with normal or elevated EPO levels (normal limits 2.9- 25.9 mU/ml) and no JAK2 V617F gene mutation
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous positive airway pressure
DeviceNocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed)
Conventional pharmacological treatment
DrugUsual treatment of the patient
Sleep ,diet and life style recomendations
Other interventionDaily recomendatios
Treatment groups
182 Participants
are divided into 2 treatment groupsGroup A: CPAP treatmentExperimental treatment 3 interventions
Group B: Control treatmentActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline of hematocrit
To compare the change in hematocrit in blood patients between the patients allocated to CPAP group and the control group
Time frame
12 monthsSecondary outcomes
1
Change from baseline of hemoglobin
To compare the change in hemoglobin in blood patients between the patients allocated to CPAP group and the control group
Time frame
12 months2
Change from baseline in the health-related quality of life assessed by the Euroqol-5
The 5-level EQ-5D version (EQ-5D-5L) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scal fom 0 to 100 points.
Time frame
12 months3
Relationship between hypoxic burden and hemoglobin and hematocrit
HB was defined as the total area under the oxygen saturation curve from a pre-event baseline oxygen desaturation. For each apnea and hypopnea the termination of the event is called "time-zero". The oxygen saturation signals around time-zero are synchronized with respect to time-zero.The time-aligned oxygen saturation signals are ensemble-averaged such that the mean value at each time point is calculated, resulting in a subject-specific average oxygen saturation curve specific to apneas and hypopneas.A subject-specific search window to quantify the area under the desaturation curve for each event is defined as the interval between the pre-event and post-event maximum oxygen saturation values. This time-locked search window will be used to determine the start and end of oxygen desaturation and calculate the area under desaturation curve for each respiratory event.Total HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h).
Time frame
12 months4
Change from baseline in sleepiness assessed by Epworth scale
To compare the change in the total score and the domains of the Epworth sleepiness scale between the CPAP group and the control group. The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Interpretation: 0-7:It is unlikely that you are abnormally sleepy. 8-9:You have an average amount of daytime sleepiness. 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24:You are excessively sleepy and should consider seeking medical attention.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov