CPAP Effect on the Polycythemia in Patients With Obstructive Sleep Apnea

NCT06089603 | Recruiting Phase 4

• 1 other identifier: HURyC 207/23
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Polycythemia

Outcome Measures

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

  12 months

Secondary Outcomes (5)

• Change from baseline of hemoglobin

  12 months

• Change from baseline in the health-related quality of life assessed by the Euroqol-5

  12 months

• Relationship between hypoxic burden and hemoglobin and hematocrit

  12 months

• Change from baseline in sleepiness assessed by Epworth scale

  12 months

• Relationship between night time below SaO2 90% (T90) and oxygen desaturation index (ODI) and hematocrit

  12 months

Study Arms (2)

CPAP treatment

EXPERIMENTAL

Diet and conventional pharmacological treatment plus continuous positive airway pressure (CPAP)

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

Drug: Conventional pharmacological treatment; Other: Sleep ,diet and life style recomendations

Interventions

Continuous positive airway pressure DEVICE

Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed)

Also known as: CPAP

CPAP treatment

Conventional pharmacological treatment DRUG

Usual treatment of the patient

CPAP treatment; Control treatment

Sleep ,diet and life style recomendations OTHER

Daily recomendatios

Also known as: Conventional recomendations

CPAP treatment; Control treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Aldara García-Sanchez

Madrid, Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Polycythemia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Aldara García-Sanchez, MD, phD

  Hospital Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldara García-Sanchez, MD, phD

CONTACT

+34686810368; aldara.garcia.ag@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, pHD

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 18, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)