Masked Hypertensive Patients With Obstructive Sleep Apnea

NCT04251975 | Completed

• 1 other identifier: 2131-Masked-OSA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The general objective is to evaluate the effect of continuous positive airway pressure (CPAP) treatment in patients with masked hypertension. The secondary objectives are: i) To evaluate the prevalence of different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) (dipper / non-dipper); ii) To assess in these patients the relationship between compliance with CPAP treatment and the response to nocturnal BP; iii) To identify variables of the ABPM, and biomarkers that are related to the unfavourable pattern of nocturnal BP response in these patients treated with CPAP; iv) To evaluate the change in the profile of biomarkers with the treatment. Methodology: Open, parallel, prospective, randomized and controlled study in which an ABPM will be performed in individuals with masked hypertension referred to the sleep unit and diagnosed of OSA (AHI≥ 30) without sleepiness (Epworth≤18). A total of 64 subjects with OSA and masked hypertension will be recruited. It will be collected blood for the determination of biomarkers. Subsequently, they will be randomized to receive treatment with CPAP (32) or conservative treatment (32). After 3 months of initiation, ABPM and biological determinations will be repeated.

Conditions

Obstructive Sleep Apnea; Masked Hypertension

Keywords

Obstructive sleep apnea; Masked hypertension

Outcome Measures

Primary Outcomes (1)

• Effect of CPAP treatment on BP in masked hypertensive patients with severe OSA

  Change in mmHg in the blood pressure of the ambulatory blood pressure monitoring parameters after the treatment

  3 years

Secondary Outcomes (4)

• Prevalence of the different circadian BP patterns (dipper/no-dipper) in the ABPM of masked hypertensive subjects diagnosed with severe OSA without significant somnolence (Epworth≤18)

  3 years

• Association between CPAP use and blood pressure change in ABPM

  3 years

• Ambulatory blood pressure parameters that could be related to the response to CPAP treatment

  3 years

• Changes in the biomarkers' profile (mRNAs) after CPAP treatment

  3 years

Study Arms (2)

CPAP treatment

EXPERIMENTAL

Group of patients who will receive CPAP treatment

Device: CPAP treatment

Conservative measures

NO INTERVENTION

Group of patients who will receive conservative treatment based on hygienic-dietetic measures

Interventions

CPAP treatment DEVICE

In this group of patients (CPAP group) will be prescribed CPAP treatment at an optimal pressure. It will be performed a CPAP titration with an automatic or manual CPAP according to usual clinical practice

CPAP treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years of age
• Referred to the sleep unit for suspected OSA
• Being masked hypertensive and presenting an AHI≥ 30 in the sleep study
• Signature of the informed consent.

You may not qualify if:

• Previous CPAP treatment
• Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18
• Psychophysical inability to complete questionnaires
• Previous diagnosis or suspicion of another sleep disorder
• Presence of more than 50% of central apneas or Cheyne-Stokes respiration
• Having a serious chronic disease: neoplasia, renal failure, severe chronic obstructive pulmonary disease, chronic depression and other chronic limiting diseases
• Medical history that may interfere with the objectives of the study or, in the opinion of the researcher, may compromise the conclusions
• Any medical, social or geographical factor that may endanger the patient's compliance
• Having a profession of high risk (professional driver).

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Masked Hypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ferran Barbé Illa, MD

  CIBERES, SEPAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pulmonology

Model Details: This is an open-label, parallel, prospective, randomized and controlled trial.

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: February 5, 2020
• Study Start: April 1, 2020
• Primary Completion: January 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

ES (1)