Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

Sociedad Española de Neumología y Cirugía Torácica

Status

Enrolling

Conditions

Normotensive

Sleep Apnea, Obstructive

Treatments

Device: CPAP treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03948373

Dipper-OSA

Details and patient eligibility

About

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.

Full 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 dipper 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:
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.
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 (T0), at first month (T1) and at three months (T2), during the follow-up period.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
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 9-Having a profession of high risk (professional driver).