Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness
Primary Purpose
Sleep Apnea, Hypertension, Cardiovascular Diseases
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
CPAP (Continuous Positive Airway Pressure)
Sponsored by
About this trial
This is an interventional prevention trial for Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Hospital Univ Arnau de Vilanova
Outcomes
Primary Outcome Measures
Incidence of hypertension
Incidence of cardiovascular events
Secondary Outcome Measures
Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity
Relationship between cardiovascular events and SAHS severity
Full Information
NCT ID
NCT00127348
First Posted
August 4, 2005
Last Updated
April 2, 2007
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
1. Study Identification
Unique Protocol Identification Number
NCT00127348
Brief Title
Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness
Official Title
Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients With Sleep Apnea and Without Daytime Sleepiness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Hypertension, Cardiovascular Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CPAP (Continuous Positive Airway Pressure)
Primary Outcome Measure Information:
Title
Incidence of hypertension
Title
Incidence of cardiovascular events
Secondary Outcome Measure Information:
Title
Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity
Title
Relationship between cardiovascular events and SAHS severity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferran Barbe, MD
Organizational Affiliation
Hospital Universitari Arnau de Vilanova. Lleida. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Univ Arnau de Vilanova
City
Lleida
State/Province
Catalonia
ZIP/Postal Code
25198
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
34739082
Citation
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.
Results Reference
derived
PubMed Identifier
23372475
Citation
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.
Results Reference
derived
PubMed Identifier
22837377
Citation
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.
Results Reference
derived
PubMed Identifier
22618923
Citation
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.
Results Reference
derived
PubMed Identifier
20007932
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness
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