Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Effect of CPAP treatment on BP according to the circadian BP pattern in normotensive dipper patients with severe OSA [Срок оценки: 3 years]

Вторичные конечные точки (4)

• 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) [Срок оценки: 3 years]
• Relationship between compliance with CPAP treatment and the blood pressure change in these patients [Срок оценки: 3 years]
• Ambulatory blood pressure parameters different to circadian blood pressure that are related to the response to CPAP treatment [Срок оценки: 3 years]
• Changes in the biomarkers' profile after CPAP treatment [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 9-Having a profession of high risk (professional driver).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Arnau de Vilanova-Santa Maria — Lleida

Идентификаторы

NCT: NCT03948373 · Dipper-OSA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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