Evaluating CPAP treatment effects on blood pressure in normotensive sleep apnea patients
CPAP Effect in Nocturnal Blood Pressure in Normotensive Patients With Dipper Circadian Pattern and Severe Obstructive Sleep Apnea (OSA)
This study is testing if using a CPAP machine can help lower blood pressure in people with severe sleep apnea who normally have healthy blood pressure levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sociedad Española de Neumología y Cirugía Torácica Academic / other |
| Locations | 1 site (Lleida) |
| Trial ID | NCT03948373 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of Continuous Positive Airway Pressure (CPAP) treatment on blood pressure in normotensive patients diagnosed with severe obstructive sleep apnea-hypopnea syndrome (SAHS) who exhibit a dipper circadian blood pressure pattern. The trial will include 64 participants who will be randomly assigned to receive either CPAP treatment or conservative care for three months. The study will also evaluate the prevalence of different circadian blood pressure patterns and the relationship between CPAP compliance and blood pressure response, alongside biomarker changes. Blood pressure monitoring and blood sample collection will occur at the start and after three months of treatment.
Who should consider this trial
Good fit: Ideal candidates are normotensive adults over 18 years old with severe obstructive sleep apnea and a dipper circadian blood pressure pattern.
Not a fit: Patients with significant somnolence, previous CPAP treatment, or other serious chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood pressure management in patients with sleep apnea, enhancing their overall health outcomes.
How similar studies have performed: While similar studies have explored CPAP effects on blood pressure, this specific focus on normotensive patients with a dipper pattern is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men and women over 18 years of age 2. Referred to the sleep unit for suspected OSA 3. Being normotensive and presenting an AHI ≥ 30 in the sleep study 4. Signature of the informed consent. Exclusion Criteria: 1. Previous CPAP treatment 2. Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18 3. Psychophysical inability to complete questionnaires 4. Previous diagnosis or suspicion of another sleep disorder 5. Presence of more than 50% of central apneas or Cheyne-Stokes respiration 6. Having a serious chronic disease: neoplasia, renal failure, severe chronic obstructive pulmonary disease, chronic depression and other chronic limiting diseases 7. Medical history that may interfere with the objectives of the study or, in the opinion of the researcher, may compromise the conclusions 8. Any medical, social or geographical factor that may endanger the patient's compliance 9-Having a profession of high risk (professional driver).
Where this trial is running
Lleida
- Hospital Arnau de Vilanova-Santa Maria — Lleida, Spain (Recruiting)
Study contacts
- Principal investigator: Ferran Barbé Illa, MD — Separ, Ciberes
- Study coordinator: Ferran Barbé Illa, MD
- Email: febarbe.lleida.ics@gencat.cat
- Phone: +34 (973) 70 53 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.