NCT03987425

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

4.3 years

First QC Date

June 10, 2019

Last Update Submit

November 21, 2023

Conditions

NormotensiveObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    3 years

  • Relationship between compliance with CPAP treatment and the blood pressure change in normotensive nondipper patients with OSA

    3 years

  • Identify predictors of nocturnal blood pressure response to CPAP treatment

    3 years

  • Changes in the biomarkers' profile (miRNAs) in normotensive nondipper-OSA patients 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

Group of patients who will receive conservative treatment based on hygienic-dietetic measures

Interventions

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.

CPAP treatment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Having a profession of high risk (professional driver).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferran Barbé

Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

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
Medical Doctor, Chair Respiratory Medicine

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 17, 2019

Study Start

June 1, 2019

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

ES(1)