Evaluating CPAP treatment effects on blood pressure in normotensive sleep apnea patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.