NCT00127348

Brief Summary

The objective of the study is to evaluate the effect of CPAP over the incidence of cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea. The hypothesis of the study is the following: The existence of sleep disordered breathing in the general population is associated to an increased incidence of arterial hypertension and to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular complications. The end points of the study are new diagnosis of arterial hypertension and new cardiovascular events. All patients, after randomization, will be followed for three years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

April 4, 2007

Status Verified

April 1, 2006

First QC Date

August 4, 2005

Last Update Submit

April 2, 2007

Conditions

Sleep ApneaHypertensionCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • Incidence of hypertension

  • Incidence of cardiovascular events

Secondary Outcomes (2)

  • Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity

  • Relationship between cardiovascular events and SAHS severity

Interventions

CPAP (Continuous Positive Airway Pressure)DEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Epworth \<10
  • Apnea-Hypopnea Index ≥20

You may not qualify if:

  • Presence of any chronic disease
  • Presence of cardiovascular disease
  • Refusal to sign informed consent
  • Drug addiction and/or alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Univ Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

Location

Related Publications (5)

  • Reynor A, McArdle N, Shenoy B, Dhaliwal SS, Rea SC, Walsh J, Eastwood PR, Maddison K, Hillman DR, Ling I, Keenan BT, Maislin G, Magalang U, Pack AI, Mazzotti DR, Lee CH, Singh B. Continuous positive airway pressure and adverse cardiovascular events in obstructive sleep apnea: are participants of randomized trials representative of sleep clinic patients? Sleep. 2022 Apr 11;45(4):zsab264. doi: 10.1093/sleep/zsab264.

    PMID: 34739082DERIVED

  • Phillips B, Shafazand S. CPAP and hypertension in nonsleepy patients. J Clin Sleep Med. 2013 Feb 1;9(2):181-2. doi: 10.5664/jcsm.2426.

    PMID: 23372475DERIVED

  • Weaver TE, Mancini C, Maislin G, Cater J, Staley B, Landis JR, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Gurubhagavatula I, Kuna ST. Continuous positive airway pressure treatment of sleepy patients with milder obstructive sleep apnea: results of the CPAP Apnea Trial North American Program (CATNAP) randomized clinical trial. Am J Respir Crit Care Med. 2012 Oct 1;186(7):677-83. doi: 10.1164/rccm.201202-0200OC. Epub 2012 Jul 26.

    PMID: 22837377DERIVED

  • Barbe F, Duran-Cantolla J, Sanchez-de-la-Torre M, Martinez-Alonso M, Carmona C, Barcelo A, Chiner E, Masa JF, Gonzalez M, Marin JM, Garcia-Rio F, Diaz de Atauri J, Teran J, Mayos M, de la Pena M, Monasterio C, del Campo F, Montserrat JM; Spanish Sleep And Breathing Network. Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial. JAMA. 2012 May 23;307(20):2161-8. doi: 10.1001/jama.2012.4366.

    PMID: 22618923DERIVED

  • Barbe F, Duran-Cantolla J, Capote F, de la Pena M, Chiner E, Masa JF, Gonzalez M, Marin JM, Garcia-Rio F, de Atauri JD, Teran J, Mayos M, Monasterio C, del Campo F, Gomez S, de la Torre MS, Martinez M, Montserrat JM; Spanish Sleep and Breathing Group. Long-term effect of continuous positive airway pressure in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Apr 1;181(7):718-26. doi: 10.1164/rccm.200901-0050OC. Epub 2009 Dec 10.

    PMID: 20007932DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesHypertensionCardiovascular Diseases

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Ferran Barbe, MD

    Hospital Universitari Arnau de Vilanova. Lleida. Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 5, 2005

Study Start

May 1, 2004

Study Completion

April 1, 2006

Last Updated

April 4, 2007

Record last verified: 2006-04

Locations

ES(1)