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Normotensive OSA Patients With Nondipper Circadian Blood Pressure Pattern (Nondipper-OSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03987425
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Societat Catalana de Pneumologia
Information provided by (Responsible Party):
Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica

Brief Summary:

The principal objective is to evaluate the effect of CPAP treatment on blood pressure (BP) in normotensive patients with nondipper 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 after CPAP treatment.

Methodology: Open-label, parallel, prospective, randomized and controlled trial including normotensive patients with nondipper circadian pattern diagnosed with severe SAHS without significant somnolence. 64 patients with nondipper 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.

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

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 nondipper 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:

    • 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.
    • 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 the 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Intervention With Continuous Positive Pressure (CPAP) on Nocturnal Blood Pressure (BP) in Normotensive Patients With Nondipper Circadian Pattern and Sleep Apnea-hypopnea Syndrome (SAHS)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
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 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 normotensive nondipper patients with severe OSA [ Time Frame: 3 years ]
    Change in mmHg in blood pressure monitoring parameters after 3 months of treatment

Secondary Outcome Measures :
  1. Prevalence of the different circadian BP patterns (dipper /nondipper) 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

  2. Relationship between compliance with CPAP treatment and the blood pressure change in normotensive nondipper patients with OSA [ 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. Identify predictors of nocturnal blood pressure response to CPAP treatment [ Time Frame: 3 years ]
    Among all the variables recorded in the 24h-ambulatory blood pressure monitoring (different to circadian blood pressure) the investigators will proceed to the identification of variables that are related to the change in mean nocturnal BP in normotensive nondipper-OSA patients treated with CPAP.

  4. Changes in the biomarkers' profile (miRNAs) in normotensive nondipper-OSA patients after CPAP treatment [ Time Frame: 3 years ]

    The miRNAs profile will be evaluated at baseline and after 3 months of CPAP treatment in order to evaluate changes related to CPAP treatment.

    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 polymerase chain reaction (PCR) amplification of the genes for which the investigators 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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

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 identifier (NCT number): NCT03987425

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Contact: Ferran Barbé Illa, MD (+34) 973705372

Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Societat Catalana de Pneumologia

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Responsible Party: Ferran Barbe, Medical Doctor, Chair Respiratory Medicine, Sociedad Española de Neumología y Cirugía Torácica Identifier: NCT03987425     History of Changes
Other Study ID Numbers: Nondipper-OSA
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases