Actively Recruiting
Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern
Led by Sociedad Española de Neumología y Cirugía Torácica · Updated on 2025-02-26
64
Participants Needed
1
Research Sites
342 weeks
Total Duration
On this page
Sponsors
S
Sociedad Española de Neumología y Cirugía Torácica
Lead Sponsor
S
Societat Catalana de Pneumologia
Collaborating Sponsor
AI-Summary
What this Trial Is About
The principal objective is to evaluate the effect of CPAP treatment on blood pressure (BP) in normotensive patients with dipper circadian pattern with sleep apnea-hypopnea syndrome (SAHS). The secondary objectives are: i) To evaluate the prevalence of the different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) ii) To establish the relationship between CPAP compliance and BP response; iii) Identify which ABPM variables and biomarkers are related to BP response; iv) Evaluate changes in the biomarkers' profile with the CPAP treatment. Methodology: Open-label, parallel, prospective, randomized and controlled trial including normotensive patients diagnosed with severe SAHS without significant somnolence. 64 patients with dipper circadian pattern will be included and will be randomized to receive CPAP (32) or conservative treatment (32). ABPM and blood sample collection will be performed at the beginning of the study and at 3 months.
CONDITIONS
Official Title
Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women over 18 years of age
- Referred to the sleep unit for suspected obstructive sleep apnea
- Normotensive with apnea-hypopnea index (AHI) of 30 or higher in sleep study
- Signed informed consent
You will not qualify if you...
- Previous CPAP treatment
- Significant daytime sleepiness with Epworth Sleepiness Scale score above 18
- Inability to complete questionnaires due to psychophysical reasons
- Previous diagnosis or suspicion of other sleep disorders
- More than 50% central apneas or Cheyne-Stokes respiration
- Serious chronic diseases such as cancer, renal failure, severe COPD, chronic depression, or other limiting diseases
- Medical history affecting study objectives or conclusions
- Any medical, social, or geographic factor risking patient compliance
- Occupation involving high risk (e.g., professional driver)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Arnau de Vilanova-Santa Maria
Lleida, Spain, 25198
Actively Recruiting
Research Team
F
Ferran Barbé Illa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here