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Masked Hypertensive Patients With Obstructive Sleep Apnea (Masked-OSA)

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ClinicalTrials.gov Identifier: NCT04251975
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Masked Hypertension Device: CPAP treatment Not Applicable

Detailed Description:

Recruitment: It will be recruited subjects with masked hypertension. For that, normotensive subjects (Blood pressure (BP)<140/90mmHg in the office) referred to the sleep unit of the Hospital Santa Maria (Spain) who are diagnosed of severe OSA (AHI≥30) by a sleep study and who do not present significant somnolence (Epworth≤18) will be proposed to participate in the study. Then, it will be performed an ABPM during-24 hours, and those subjects with an abnormal ABPM results and normal BP in the office will be included, are those subjects called masked hypertensive.

Definition of the groups: Patients will be randomized to receive one of the following treatments:

  1. CPAP: Patients who will receive CPAP treatment. The CPAP titration will be carried out with an automatic or manual CPAP according to usual clinical practice.
  2. Conservative treatment: Patients who will receive conservative treatment based on hygienic-dietetic measures.

Randomization: It will be carried out with an automated platform

Duration of the treatment: All patients randomized to CPAP will begin treatment as soon as possible after randomization, and will continue treatment until the study ends (3 months).

Patients who interrupt treatment will be excluded from the study. ABPM and blood sample collection will be performed on all included patients at the beginning of the study and at 3 months under treatment (CPAP or conservative care).

Follow-up: All patients will be evaluated at the beginning of the study, at first month and at three months during the follow-up period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open-label, parallel, prospective, randomized and controlled trial.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intervention With Continuous Positive Pressure (CPAP) on Nocturnal Blood Pressure (BP) in Patients With Masked Hypertension and Sleep Apnea
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: CPAP treatment
Group of patients who will receive CPAP treatment
Device: CPAP treatment
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

No Intervention: Conservative measures
Group of patients who will receive conservative treatment based on hygienic-dietetic measures



Primary Outcome Measures :
  1. Effect of CPAP treatment on BP in masked hypertensive patients with severe OSA [ Time Frame: 3 years ]
    Change in mmHg in the blood pressure of the ambulatory blood pressure monitoring parameters after the treatment


Secondary Outcome Measures :
  1. 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) [ Time Frame: 3 years ]
    The prevalence of each circadian patterns will be calculated from the baseline ambulatory blood pressure monitoring data

  2. Association between CPAP use and blood pressure change in ABPM [ Time Frame: 3 years ]
    The relation between CPAP compliance (hours/night) and changes in mean nighttime BP (mmHg) between baseline and at 3-months in ABPM measurements will be assesed

  3. Ambulatory blood pressure parameters that could be related to the response to CPAP treatment [ Time Frame: 3 years ]
    Using all the ABPM variables we will proceed to the identification of variables that are related to the change in mean nocturnal BP in patients treated with CPAP

  4. Changes in the biomarkers' profile (mRNAs) after CPAP treatment [ Time Frame: 3 years ]

    Using the blood samples obtained in the baseline and 3 months visit it will be evaluated possible changes in the biomarkers profile after CPAP treatment.

    Learning Phase: complete profile analysis (754 miRNAs) will be carried out in 24 patients Learning Phase: complete profile analysis (754 miRNAs) will be carried out in 24 patients representative of the change in BP in treated patients. The miRNAs associated with the change in BP will be identified from the 754 miRNAs potentially present in serum and plasma.

    Validation Phase: Specific primers will be designed for the real-time PCR amplification of the genes for which we have found a significant association The miRNAs found will be analyzed after 3 months of treatment. Analysis of biomarkers. Immunoassay techniques will evaluate the following markers before and after treatment: angiotensin I, II and III, plasma renin activity, atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP) and endogenous ouabain.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251975


Contacts
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Contact: Ferran Barbé Illa, MD (+34) 97370 53 72 febarbe.lleida.ics@gencat.cat

Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
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Principal Investigator: Ferran Barbé Illa, MD CIBERES, SEPAR
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Responsible Party: Ferran Barbe, Head of Pulmonology, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT04251975    
Other Study ID Numbers: 2131-Masked-OSA
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica:
Obstructive sleep apnea
Masked hypertension
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertension
Masked Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases