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 |
Definition of the groups: Patients will be randomized to receive one of the following treatments:
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).
| 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) |
| Actual Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | April 2022 |
| 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
|
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.
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Ferran Barbé Illa, MD | (+34) 973705372 | febarbe.lleida.ics@gencat.cat |
| Spain | |
| Ferran Barbé | Recruiting |
| Lleida, Spain, 25198 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||
| First Posted Date ICMJE | June 17, 2019 | ||||
| Last Update Posted Date | March 22, 2021 | ||||
| Actual Study Start Date ICMJE | June 1, 2019 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Normotensive OSA Patients With Nondipper Circadian Blood Pressure Pattern | ||||
| Official Title ICMJE | 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) | ||||
| 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. |
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| Detailed Description |
|
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
|
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| Intervention ICMJE | 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.
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
64 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | April 2022 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03987425 | ||||
| Other Study ID Numbers ICMJE | Nondipper-OSA | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica | ||||
| Study Sponsor ICMJE | Sociedad Española de Neumología y Cirugía Torácica | ||||
| Collaborators ICMJE | Societat Catalana de Pneumologia | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Sociedad Española de Neumología y Cirugía Torácica | ||||
| Verification Date | March 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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