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Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

ConditionsNormotensiveSleep Apnea, Obstructive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSociedad Española de Neumología y Cirugía Torácica

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: CPAP treatmentExperimental treatment 1 intervention
Group B: Conservative measuresNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Effect of CPAP treatment on BP according to the circadian BP pattern in normotensive dipper patients with severe OSA

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

Time frame
3 years

Secondary outcomes

1

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)

The prevalence of each circadian patterns will be calculated from the baseline ambulatory blood pressure monitoring data

Time frame
3 years
2

Relationship between compliance with CPAP treatment and the blood pressure change in these patients

The relation between CPAP compliance (mean hours per night) and change in mean nighttime BP using multivariate models in patients randomized to CPAP treatment.

Time frame
3 years
3

Ambulatory blood pressure parameters different to circadian blood pressure that are related to the response to CPAP treatment

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.

Time frame
3 years
4

Changes in the biomarkers' profile after CPAP treatment

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.

Time frame
3 years

Other outcomes

Sponsors and contacts

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Sociedad Española de Neumología y Cirugía Torácica

Lead sponsor

Societat Catalana de Pneumologia

Collaborator

Source ClinicalTrials.gov
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