Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness

Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients With Sleep Apnea and Without Daytime Sleepiness

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Sleep Apnea
• Intervention / Treatment: Device: CPAP (Continuous Positive Airway Pressure)

• Study Type: Interventional
• Enrollment: 700
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Lleida, Catalonia, Spain, 25198
      • Hospital Univ Arnau de Vilanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Epworth <10
• Apnea-Hypopnea Index ≥20

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of cardiovascular events
Incidence of hypertension

Secondary Outcome Measures

Outcome Measure
Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity
Relationship between cardiovascular events and SAHS severity

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Investigators: Principal Investigator: Ferran Barbe, MD, Hospital Universitari Arnau de Vilanova. Lleida. Spain

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Study Completion: April 1, 2006

Study Registration Dates

• First Submitted: August 4, 2005
• First Submitted That Met QC Criteria: August 4, 2005
• First Posted (Estimate): August 5, 2005

Study Record Updates

• Last Update Posted (Estimate): April 4, 2007
• Last Update Submitted That Met QC Criteria: April 2, 2007
• Last Verified: April 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Hypertension; Cardiovascular Diseases; Apnea; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: PI 040165