Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

February 25, 2025 updated by: Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Recruitment: Normotensive subjects referred to the sleep unit of the Hospital Santa Maria (Spain) who are diagnosed of severe OSA (AHI≥30) by a sleep study and dipper circadian blood pattern confirmed by ABPM and who do not present significant somnolence (Epworth≤18) will be included in the study.

  2. 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.
  3. Randomization: It will be carried out with an automated platform

  4. 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).

  5. Follow-up: All patients will be evaluated at the beginning of the study (T0), at first month (T1) and at three months (T2), during the follow-up period.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital Arnau de Vilanova-Santa Maria
        • Contact:
          • Ferran Barbe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women over 18 years of age
  2. Referred to the sleep unit for suspected OSA
  3. Being normotensive 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Patients who will receive conservative treatment based on hygienic-dietetic measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of CPAP treatment on BP according to the circadian BP pattern in normotensive dipper 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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of the different circadian BP patterns (dipper/no-dipper) in the ABPM of normotensive 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
3 years
Relationship between compliance with CPAP treatment and the blood pressure change in these patients
Time Frame: 3 years
The relation between CPAP compliance (mean hours per night) and change in mean nighttime BP using multivariate models in patients randomized to CPAP treatment.
3 years
Ambulatory blood pressure parameters different to circadian blood pressure that are 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.
3 years
Changes in the biomarkers' profile after CPAP treatment
Time Frame: 3 years

Using the 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Collaborators

Societat Catalana de Pneumologia

Investigators

  • Principal Investigator: Ferran Barbé Illa, MD, SEPAR, CIBERES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dipper-OSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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