Intermitent Hypoxia and Its Pathophysiology Consequences in the Sleep Apnea-Hypopnea Syndrome.

NCT04444778 | Enrolling By Invitation

• 1 other identifier: PI19/00875
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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 whether the results obtained in vitro on the recovery of the damage according to the form of manifestation of IH are validated in SAHS patients. 3) To determine if CPAP reduces nighttime blood pressure and arterial stiffness depending on whether or not patients have a non-dipping pattern of blood pressure and depending on the degree of correction of IH. 4) To clarify whether residual nocturnal hypoxemia influences the recovery of oxidative and inflammatory damage in patients. 5) To determine nasal and intestinal microbioma and the effect of CPAP treatment

Conditions

Sleep Apnea, Obstructive

Keywords

sleep apnea syndrome

Outcome Measures

Primary Outcomes (7)

• Change from baseline in 8 isoprostane levels

  To compare the change in 8 isoprostane levels between the patients allocated to CPAP group and the control group

  4 months

• Change from baseline in microbiota population diversity from stool samples

  To compare the change in in microbiota population diversity, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group

  4 months

• Change from baseline in microbiota population diversity from nasopharyngeal samples

  To compare the change in microbiota population diversity, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group

  4 months

• Change from baseline in microbiota population abundance from stool samples

  To compare the change in microbiota population abundance, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group

  4 months

• Change from baseline in microbiota population abundance from nasopharyngeal samples

  To compare the change in microbiota population abundance, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group

  4 months

• Change from baseline in microbiota population color maps from stool samples

  To compare the change in microbiota population color maps, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group

  4 months

• Change from baseline in microbiota color maps from nasopharyngeal samples

  To compare the change in microbiota population color maps, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group

  4 months

Secondary Outcomes (33)

• Augmentation index (%)

  Baseline and 4 months

• Pulse wave velocity (m/sec)

  Baseline and 4 months

• Aortic systolic blood pressure central (mmHg)

  Baseline and 4 months

• Diastolic blood pressure central (mmHg)

  Baseline and 4 months

• Subendocardial viability ratio (%)

  Baseline and 4 months

Study Arms (2)

Continuous positive airway pressure

ACTIVE COMPARATOR

Diet and general life style recommendations plus continuous positive airway pressure (CPAP).

Device: CPAP

Conservative treatment

NO INTERVENTION

Diet and general life style recommendations.

Interventions

CPAP DEVICE

Continuous positive airway pressure

Continuous positive airway pressure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases: patients with AHI \> 30
• Controls: subjects with AHI \< 5 and Epworth \>10

You may not qualify if:

• 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

Sponsors & Collaborators

• Alberto Alonso Fernandez: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (2)

Hospital Son Espases

Palma, Balearic Islands, 07006, Spain

Location

Hospital Son Llatzer

Palma, Balearic Islands, 07006, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Alberto Alonso, Dr

  Fundació d'investigació Sanitària de les Illes Balears

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 24, 2020
• Study Start: July 20, 2020
• Primary Completion: April 16, 2025
• Study Completion: May 6, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)