CPAP Effect in Nocturnal Blood Pressure in Normotensive Patients With Dipper Circadian Pattern and Severe Obstructive Sleep Apnea (OSA)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Men and women over 18 years of age

• Referred to the sleep unit for suspected OSA

• Being normotensive and presenting an AHI ≥ 30 in the sleep study

• Signature of the informed consent.

Locations
Other Locations
Spain
Hospital Arnau de Vilanova-Santa Maria
RECRUITING
Lleida
Contact Information
Primary
Ferran Barbé Illa, MD
febarbe.lleida.ics@gencat.cat
+34 (973) 70 53 72
Time Frame
Start Date: 2019-05-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 64
Treatments
Experimental: CPAP treatment
Group of patients who will receive CPAP treatment
No_intervention: Conservative measures
Patients who will receive conservative treatment based on hygienic-dietetic measures
Related Therapeutic Areas
Sponsors
Collaborators: Societat Catalana de Pneumologia
Leads: Sociedad Española de Neumología y Cirugía Torácica

This content was sourced from clinicaltrials.gov