Status:
ENROLLING_BY_INVITATION
Intermitent Hypoxia and Its Pathophysiology Consequences in the Sleep Apnea-Hypopnea Syndrome.
Lead Sponsor:
Alberto Alonso Fernandez
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Clinical trial on the effect of continuous positive pressure (CPAP). Objectives: 1) To assess the total or partial recovery of oxidative and inflammatory damage after recovering IH. 2) To check whethe...
Detailed Description
Design: Randomized, parallel group, non-blinded, controlled clinical trial compared with conventional treatment. A. Protocol and intervention Patients with an AHI\>30 h-1 will be assigned, using a 1:...
Eligibility Criteria
Inclusion
- Cases: patients with AHI \> 30
- Controls: subjects with AHI \< 5 and Epworth \>10
Exclusion
- Epworth\>18
- BMI\<40Kg/M2
- Arterial Hypertension
- Mellitus Diabetes
- Cerebrovascular disease
- Ischemic heart disease
- Cardiac arrhythmia
- Chronic cardiovascular diseases
- Daytime Oxygen saturation\>95%
- Risk professions (professional drivers)
- Concomitant treatment with antihypertensives, statins, antidiabetics, beta-blockers or systemics corticosteroids.
- Pretreatment with CPAP.
- Participation in another clinical trial thirty days prior to randomization
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 6 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04444778
Start Date
July 20 2020
End Date
May 6 2025
Last Update
May 1 2025
Active Locations (2)
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1
Hospital Son Espases
Palma, Balearic Islands, Spain, 07006
2
Hospital Son Llatzer
Palma, Balearic Islands, Spain, 07006