Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

NCT ID: NCT03948373

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

1. 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 dipper circadian blood pattern confirmed by ABPM and who do not present significant somnolence (Epworth≤18) will be included in the study.

2. Definition of the groups: Patients will be randomized to receive one of the following treatments:

1. 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.

2. Conservative treatment: Patients who will receive conservative treatment based on hygienic-dietetic measures.

3. Randomization: It will be carried out with an automated platform

4. 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).

5. 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; Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CPAP treatment

Group of patients who will receive CPAP treatment

Group Type: EXPERIMENTAL

CPAP treatment

Intervention Type: 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.

Conservative measures

Patients who will receive conservative treatment based on hygienic-dietetic measures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CPAP treatment

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Men and women over 18 years of age

2. Referred to the sleep unit for suspected OSA

3. Being normotensive and presenting an AHI ≥ 30 in the sleep study

4. Signature of the informed consent.

Exclusion Criteria

1. Previous CPAP treatment

2. Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18

3. Psychophysical inability to complete questionnaires

4. Previous diagnosis or suspicion of another sleep disorder

5. Presence of more than 50% of central apneas or Cheyne-Stokes respiration

6. Having a serious chronic disease: neoplasia, renal failure, severe chronic obstructive pulmonary disease, chronic depression and other chronic limiting diseases

7. Medical history that may interfere with the objectives of the study or, in the opinion of the researcher, may compromise the conclusions

8. Any medical, social or geographical factor that may endanger the patient's compliance 9-Having a profession of high risk (professional driver).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: lead

Societat Catalana de Pneumologia

UNKNOWN

Sponsor Role: collaborator

Responsible Party

Ferran Barbe

Chair Respiratory Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferran Barbé Illa, MD

Role: PRINCIPAL_INVESTIGATOR

SEPAR, CIBERES

Locations

Hospital Arnau de Vilanova-Santa Maria

Lleida, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ferran Barbé Illa, MD

Role: CONTACT

febarbe.lleida.ics@gencat.cat

+34 (973) 70 53 72

Facility Contacts

Ferran Barbe, MD

Role: primary

Other Identifiers

Dipper-OSA

Identifier Type: -

Identifier Source: org_study_id