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CompletedNCT00863135Updated Feb 9, 2017

Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension

An interventional study of CPAP and Control in Obstructive Sleep Apnea and Refractory Arterial Hypertension, sponsored by Corporacion Parc Tauli. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-09.

Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to determine the effects of CPAP treatment on blood pressure in patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH).

Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress, sympathetic hyperactivity) will be analyzed.

02

Conditions studied

  • Obstructive Sleep Apnea
  • Refractory Arterial Hypertension

Keywords

  • obstructive sleep apnea
  • refractory arterial hypertension
  • continuous positive airways pressure
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 68 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15

Exclusion criteria

Exclusion Criteria:

  • excessive sleepiness
  • professional drivers
  • secondary arterial hypertension
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Continuous Positive Airway Pressure

    nocturnal continuous positive airways pressure

    Device: CPAP

  • Other
    Control

    Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time

    Device: Control

Interventions

  • DeviceCPAP

    continuous positive airways pressure

  • DeviceControl

    Patients are 3 months without any change in their treatment, and are in the waiting list to come into the CPAP procedure after that time

06

What researchers measure

Primary outcomes

  1. 24 hours blood pressure monitoring

    Time frame: basal and after three months of CPAP treatment

Secondary outcomes

  1. oxidative stress and inflammatory mediators

    Time frame: basal and after three months of CPAP treatment

07

Study locations

1 site
  • Corporacio Parc Tauli
    Sabadell, Barcelona 08208, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00863135
Lead sponsor
Corporacion Parc Tauli
Collaborators
Carlos III Health Institute
Responsible party
Jaume Almirall (Dr., Corporacion Parc Tauli) — Principal investigator
First posted
Mar 17, 2009
Start date
Dec 2008
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Feb 9, 2017

Study contacts

Jaume Almirall, Dr
principal investigator · Corporació Parc Taulí
Juan-Carlos Martinez-Ocaña, Dr
study chair · Corporació Parc Tauli
Antonio Ferrer, Dr
study chair · Corporacio Parc Tauli

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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