An interventional study of CPAP treatment in Obstructive Sleep Apnea and Masked Hypertension, sponsored by Sociedad Española de Neumología y Cirugía Torácica. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Sociedad Española de Neumología y Cirugía Torácica · Not applicable, Interventional, and Treatment
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.
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:
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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 16 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Sociedad Española de Neumología y Cirugía Torácica is the lead sponsor of 44 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Group of patients who will receive CPAP treatment
Device: CPAP treatment
Group of patients who will receive conservative treatment based on hygienic-dietetic measures
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
Effect of CPAP treatment on BP in masked hypertensive 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
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)
The prevalence of each circadian patterns will be calculated from the baseline ambulatory blood pressure monitoring data
Time frame: 3 years
Association between CPAP use and blood pressure change in ABPM
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
Time frame: 3 years
Ambulatory blood pressure parameters that could be 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
Changes in the biomarkers' profile (mRNAs) after CPAP treatment
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.
Time frame: 3 years
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sociedad Española de Neumología y Cirugía Torácica