Back to resultsCPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea (PoliAOS)
Primary Purpose
Sleep Apnea, Obstructive, Polycythemia
Status
Not yet recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Continuous positive airway pressure
Conventional pharmacological treatment
Sleep ,diet and life style recomendations
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). 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.
Sites / Locations
- Aldara García-Sanchez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CPAP treatment
Control treatment
Arm Description
Diet and conventional pharmacological treatment plus continuous positive airway pressure (CPAP)
Diet and conventional pharmacological treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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).
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.
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
Full Information
NCT ID
NCT06089603
First Posted
September 26, 2023
Last Updated
October 13, 2023
Sponsor
Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT06089603
Brief Title
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Acronym
PoliAOS
Official Title
CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Ramon y Cajal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Polycythemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP treatment
Arm Type
Experimental
Arm Description
Diet and conventional pharmacological treatment plus continuous positive airway pressure (CPAP)
Arm Title
Control treatment
Arm Type
Active Comparator
Arm Description
Diet and conventional pharmacological treatment
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Other Intervention Name(s)
CPAP
Intervention Description
Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed)
Intervention Type
Drug
Intervention Name(s)
Conventional pharmacological treatment
Intervention Description
Usual treatment of the patient
Intervention Type
Other
Intervention Name(s)
Sleep ,diet and life style recomendations
Other Intervention Name(s)
Conventional recomendations
Intervention Description
Daily recomendatios
Primary Outcome Measure Information:
Title
Change from baseline of hematocrit
Description
To compare the change in hematocrit in blood patients between the patients allocated to CPAP group and the control group
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline of hemoglobin
Description
To compare the change in hemoglobin in blood patients between the patients allocated to CPAP group and the control group
Time Frame
12 months
Title
Change from baseline in the health-related quality of life assessed by the Euroqol-5
Description
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 months
Title
Relationship between hypoxic burden and hemoglobin and hematocrit
Description
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 months
Title
Change from baseline in sleepiness assessed by Epworth scale
Description
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 months
Title
Relationship between night time below SaO2 90% (T90) and oxygen desaturation index (ODI) and hematocrit
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aldara García-Sanchez, MD, phD
Phone
+34686810368
Email
aldara.garcia.ag@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldara García-Sanchez, MD, phD
Organizational Affiliation
Hospital Ramon y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aldara García-Sanchez
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldara Garcia-Sanchez, MD, phD
12. IPD Sharing Statement
Plan to Share IPD
No
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CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea
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