Clinical trial NCT03948373: Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern
Official title: CPAP Effect in Nocturnal Blood Pressure in Normotensive Patients With Dipper Circadian Pattern and Severe Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normotensive
Sleep Apnea, Obstructive
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Societat Catalana de Pneumologia
First posted: 2019-05-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open-label, parallel, prospective, randomized and controlled trial.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Effect of CPAP treatment on BP according to the circadian BP pattern in normotensive dipper patients with severe OSA
timeFrame: 3 years
Secondary outcomes:
measure: Prevalence of the different circadian BP patterns (dipper/no-dipper) in the ABPM of normotensive subjects diagnosed with severe OSA without significant somnolence (Epworth≤18)
timeFrame: 3 years
measure: Relationship between compliance with CPAP treatment and the blood pressure change in these patients
timeFrame: 3 years
measure: Ambulatory blood pressure parameters different to circadian blood pressure that are related to the response to CPAP treatment
timeFrame: 3 years
measure: Changes in the biomarkers' profile after CPAP treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova-Santa Maria
Study officials:
affiliation: SEPAR, CIBERES
name: Ferran Barbé Illa, MD
role: PRINCIPAL_INVESTIGATOR
References: