Obstructive Sleep ApneaMasked-OSANCT04251975
Masked Hypertensive Patients With Obstructive Sleep Apnea
A study testing CPAP treatment in people with Obstructive Sleep Apnea and Masked Hypertension, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obstructive Sleep Apnea, Masked Hypertension
- What is being tested?
- CPAP treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2020to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years of age
- Referred to the sleep unit for suspected OSA
- Being masked hypertensive and presenting an AHI≥ 30 in the sleep study
- Signature of the informed consent.
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intervention With Continuous Positive Pressure (CPAP) on Nocturnal Blood Pressure (BP) in Patients With Masked Hypertension and Sleep Apnea
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.
Read more
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.
Read the detailed description
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:
- 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.
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.
- Conditions
- Obstructive Sleep Apnea, Masked Hypertension
- Being tested
- CPAP treatment
- Keywords
- Obstructive sleep apnea, Masked hypertension
- Medical subject headings
- Sleep Apnea, Obstructive, Masked Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | Group of patients who will receive CPAP treatment Receives: Device: CPAP treatment |
| Conservative measures | No intervention | Group of patients who will receive conservative treatment based on hygienic-dietetic measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Apr 2020
- Primary completion31 Jan 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, parallel, prospective, randomized and controlled trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbé Illa, MD, Principal investigator, CIBERES, SEPAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251975
- Sponsor's protocol ID
- 2131-Masked-OSA
- Acronym
- Masked-OSA
- Status last verified
- Nov 2023
- First submitted
- 7 Jan 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intervention With Continuous Positive Pressure (CPAP) on Nocturnal Blood Pressure (BP) in Patients With Masked Hypertension and Sleep Apnea
- ClinicalTrials.gov ID
- NCT04251975
- Acronym / sponsor ID
- Masked-OSA / 2131-Masked-OSA
- Conditions
- Obstructive Sleep Apnea, Masked Hypertension
- Keywords
- Obstructive sleep apnea, Masked hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is an open-label, parallel, prospective, randomized and controlled trial.
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: CPAP treatmentGroup of patients who will receive CPAP treatment |
| Conservative measures | No intervention | –Group of patients who will receive conservative treatment based on hygienic-dietetic measures |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over 18 years of age
- Referred to the sleep unit for suspected OSA
- Being masked hypertensive and presenting an AHI≥ 30 in the sleep study
- Signature of the informed consent.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP treatmentIn 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 | Device | CPAP treatment |
Primary outcome
Effect of CPAP treatment on BP in masked hypertensive patients with severe OSA
Time frame: 3 years
Change in mmHg in the blood pressure of the ambulatory blood pressure monitoring parameters after the treatment
4 secondary outcomes
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)
Time frame: 3 years
Association between CPAP use and blood pressure change in ABPM
Time frame: 3 years
Ambulatory blood pressure parameters that could be related to the response to CPAP treatment
Time frame: 3 years
Changes in the biomarkers' profile (mRNAs) after CPAP treatment
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferran Barbé Illa, MD principal investigator
CIBERES, SEPAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP treatment in people with Obstructive Sleep Apnea and Masked Hypertension, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of CPAP treatment on BP in masked hypertensive patients with severe OSA (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.