Sleep Apnea, ObstructivePhase 4PoliAOSNCT06089603
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
A Phase 4 study testing Continuous positive airway pressure, Conventional pharmacological treatment and Sleep ,diet and life style recomendations in people with Sleep Apnea, Obstructive and Polycythemia, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Polycythemia
- What is being tested?
- Continuous positive airway pressure, Conventional pharmacological treatment and Sleep ,diet and life style recomendations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Patients with any active neoplasm will be included in the study. - Patients with chronic kidney disease (Glomerular Filtration Rate (GFR) <60 mL/min/1.73 m2).
- Patients with any active neoplasia.- Patients with chronic kidney disease (Glomerular Filtration Rate (GFR) <60 mL/min/1.73 m2).
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- Need for periodic bleeding according to hematology guidelines.
- Treatment with diuretics.
- Treatment with antiplatelets or anticoagulants.
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at the baseline visit.
- Stroke, transient ischemic attack, acute coronary syndrome or hospitalization due to worsening heart failure, in the previous 30 days .
- Professional drivers, high-risk profession or respiratory failure (according to criteria of the clinical path of diagnosis and treatment of sleep-related respiratory disorders).
- High daytime sleepiness (Epworth sleepiness scale > 16)
- Previous treatment with CPAP- Participation in another clinical trial within 30 days prior to randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Aldara García-Sanchez
Madrid, Madrid, 28034
Aldara Garcia-Sanchez, MD, phD
About this study
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.
Read more
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
- Being tested
- Continuous positive airway pressure, Conventional pharmacological treatment, Sleep ,diet and life style recomendations
- Medical subject headings
- Sleep Apnea, Obstructive, Polycythemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Also called CPAP
Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed)
Conventional pharmacological treatmentDrug
Usual treatment of the patient
Sleep ,diet and life style recomendationsOther
Also called Conventional recomendations
Daily recomendatios
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | Diet and conventional pharmacological treatment plus continuous positive airway pressure (CPAP) Receives: Device: Continuous positive airway pressure; Drug: Conventional pharmacological treatment; Other: Sleep ,diet and life style recomendations |
| Control treatment | Active comparator | Diet and conventional pharmacological treatment Receives: Drug: Conventional pharmacological treatment; Other: Sleep ,diet and life style recomendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
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
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
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.
Measured: 12 months
Relationship between night time below SaO2 90% (T90) and oxygen desaturation index (ODI) and hematocrit
T90 is the percent sleep time with SpO2 below 90%. T90 measures the desaturations that dip below a threshold of 90%. Oxygen desaturation index (ODI) is the average number of desaturation episodes per hour. It is used to characterize intermittent hypoxemia (IH), an OSA-related physiological consequence that is likely responsible for most of the pathophysiological systemic complications of OSA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Nov 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldara García-Sánchez, Hospital Universitario Ramon y Cajal
- Investigators
- Aldara García-Sanchez, MD, phD, Principal investigator, Hospital Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089603
- Sponsor's protocol ID
- HURyC 207/23
- Acronym
- PoliAOS
- Status last verified
- Mar 2025
- First submitted
- 26 Sep 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06089603
- Acronym / sponsor ID
- PoliAOS / HURyC 207/23
- Conditions
- Sleep Apnea, Obstructive, Polycythemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: Continuous positive airway pressure, Drug: Conventional pharmacological treatment, Other: Sleep ,diet and life style recomendationsDiet and conventional pharmacological treatment plus continuous positive airway pressure (CPAP) |
| Control treatment | Active comparator | Drug: Conventional pharmacological treatment, Other: Sleep ,diet and life style recomendationsDiet and conventional pharmacological treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
- Patients with any active neoplasm will be included in the study. - Patients with chronic kidney disease (Glomerular Filtration Rate (GFR) <60 mL/min/1.73 m2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressureAlso: CPAPNocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed) | Device | CPAP treatment |
| Conventional pharmacological treatmentUsual treatment of the patient | Drug | CPAP treatment, Control treatment |
| Sleep ,diet and life style recomendationsAlso: Conventional recomendationsDaily recomendatios | Other | CPAP treatment, Control treatment |
Primary outcome
Change from baseline of hematocrit
Time frame: 12 months
To compare the change in hematocrit in blood patients between the patients allocated to CPAP group and the control group
5 secondary outcomes
Change from baseline of hemoglobin
Time frame: 12 months
Change from baseline in the health-related quality of life assessed by the Euroqol-5
Time frame: 12 months
Relationship between hypoxic burden and hemoglobin and hematocrit
Time frame: 12 months
Change from baseline in sleepiness assessed by Epworth scale
Time frame: 12 months
Relationship between night time below SaO2 90% (T90) and oxygen desaturation index (ODI) and hematocrit
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aldara García-Sanchez, MD, phD principal investigator
Hospital Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous positive airway pressure, Conventional pharmacological treatment and Sleep ,diet and life style recomendations in people with Sleep Apnea, Obstructive and Polycythemia, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aldara García-Sanchez, MD, phD (+34686810368, aldara.garcia.ag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of hematocrit (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.