Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern
Key facts
- Who runs it
- Sociedad Española de Neumología y Cirugía Torácica
- Where
- Spain1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 64 people, planned
- Started
- 7 May 2019
- Planned end
- Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- CPAP treatment
- Record updated
- 26 February 2025
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous CPAP treatment
- Previous diagnosis or suspicion of another sleep disorder
- Having a serious chronic disease: neoplasia, renal failure, severe chronic obstructive pulmonary disease, chronic depression and other chronic limiting diseases
- Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18
- Psychophysical inability to complete questionnaires
- Presence of more than 50% of central apneas or Cheyne-Stokes respiration
- 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- CPAP treatmentTreatment being tested
Group of patients who will receive CPAP treatment
- Conservative measuresNo study treatment, for comparison
Patients who will receive conservative treatment based on hygienic-dietetic measures
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- CPAP Effect in Nocturnal Blood Pressure in Normotensive Patients With Dipper Circadian Pattern and Severe Obstructive Sleep Apnea (OSA)
- Fit questions
- Built from NCT03948373, who can take part
- Record updated
- 26 February 2025