NormotensiveNondipper-OSANCT03987425
Normotensive OSA Patients With Nondipper Circadian Blood Pressure Pattern
A study testing CPAP treatment in people with Normotensive and Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Normotensive, Obstructive Sleep Apnea
- 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
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 30 Sep 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 normotensive 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
Show all 9Show fewer
- 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 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)
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.
Read the detailed description
- 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 nondipper circadian blood pattern confirmed by ABPM and who do not present significant somnolence (Epworth≤18) will be included in the study.
- 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 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).
- 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.
- Conditions
- Normotensive, Obstructive Sleep Apnea
- Being tested
- CPAP treatment
- Medical subject headings
- Sleep Apnea, Obstructive
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 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 normotensive nondipper patients with severe OSA
Change in mmHg in blood pressure monitoring parameters after 3 months of treatment
Measured: 3 years
Secondary outcomes (4)
Prevalence of the different circadian BP patterns (dipper /nondipper) 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
Measured: 3 years
Relationship between compliance with CPAP treatment and the blood pressure change in normotensive nondipper patients with OSA
The relation between CPAP compliance (mean hours per night) and change in mean nighttime BP using multivariate models in patients randomized to CPAP treatment.
Measured: 3 years
Identify predictors of nocturnal blood pressure response to CPAP treatment
Among all the variables recorded in the 24h-ambulatory blood pressure monitoring (different to circadian blood pressure) the investigators will proceed to the identification of variables that are related to the change in mean nocturnal BP in normotensive nondipper-OSA patients treated with CPAP.
Measured: 3 years
Changes in the biomarkers' profile (miRNAs) in normotensive nondipper-OSA patients after CPAP treatment
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.
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 posted17 Jun 2019
- Study start1 Jun 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormotensiveStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana de Pneumologia
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987425
- Sponsor's protocol ID
- Nondipper-OSA
- Acronym
- Nondipper-OSA
- Status last verified
- Nov 2023
- First submitted
- 10 Jun 2019
- Last updated
- 22 Nov 2023
- Results posted
- 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 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)
- ClinicalTrials.gov ID
- NCT03987425
- Acronym / sponsor ID
- Nondipper-OSA / Nondipper-OSA
- Conditions
- Normotensive, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Societat Catalana de Pneumologia
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 17 Jun 2019 (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 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.
Detailed description
- 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 nondipper circadian blood pattern confirmed by ABPM and who do not present significant somnolence (Epworth≤18) will be included in the study.
- 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 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| 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 normotensive 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 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 normotensive nondipper patients with severe OSA
Time frame: 3 years
Change in mmHg in blood pressure monitoring parameters after 3 months of treatment
4 secondary outcomes
Prevalence of the different circadian BP patterns (dipper /nondipper) in the ABPM of normotensive subjects diagnosed with severe OSA without significant somnolence (Epworth≤18)
Time frame: 3 years
Relationship between compliance with CPAP treatment and the blood pressure change in normotensive nondipper patients with OSA
Time frame: 3 years
Identify predictors of nocturnal blood pressure response to CPAP treatment
Time frame: 3 years
Changes in the biomarkers' profile (miRNAs) in normotensive nondipper-OSA patients 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Normotensive and Obstructive Sleep Apnea, 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 normotensive nondipper 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.