Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

NCT03948373 | Recruiting

• 1 other identifier: Dipper-OSA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Normotensive; Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Effect of CPAP treatment on BP according to the circadian BP pattern in normotensive dipper patients with severe OSA

  Change in mmHg in the blood pressure of the ambulatory blood pressure monitoring parameters after the treatment

  3 years

Secondary Outcomes (4)

• 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)

  3 years

• Relationship between compliance with CPAP treatment and the blood pressure change in these patients

  3 years

• Ambulatory blood pressure parameters different to circadian blood pressure that are related to the response to CPAP treatment

  3 years

• Changes in the biomarkers' profile after CPAP treatment

  3 years

Study Arms (2)

CPAP treatment

EXPERIMENTAL

Group of patients who will receive CPAP treatment

Device: CPAP treatment

Conservative measures

NO INTERVENTION

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

Interventions

CPAP treatment 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.

CPAP treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Societat Catalana de Pneumologia: collaborator

Study Sites (1)

Hospital Arnau de Vilanova-Santa Maria

Lleida, 25198, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ferran Barbé Illa, MD

  SEPAR, CIBERES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferran Barbé Illa, MD

CONTACT

+34 (973) 70 53 72; febarbe.lleida.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Respiratory Medicine

Model Details: This is an open-label, parallel, prospective, randomized and controlled trial.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 13, 2019
• Study Start: May 7, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

ES (1)