Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Decrease Obstructive Sleep Apnea (OSA) Sympathetic Tone : Impact of APAP vs CPAP (APAP-CPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03428516
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : May 28, 2018
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
ResMed
Agir pour les maladies chroniques
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE January 17, 2018
First Posted Date  ICMJE February 9, 2018
Last Update Posted Date May 28, 2018
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
Sympathetic tone (MSNA) [ Time Frame: Change from baseline after one month of intervention ]
Change from Baseline Sympathetic tone at 1 months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03428516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • 24 hours Systolic Blood pressure (AMBP) [ Time Frame: Change from baseline after one month of intervention ]
    Change from Baseline in 24 hours ambulatory systolic blood pressure
  • Systolic Blood pressure (office) [ Time Frame: Change from baseline after one month of intervention ]
    Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)
  • Diastolic Blood pressure (office) change after 1 month [ Time Frame: Change from baseline after one month of intervention ]
    Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)
  • Mean Blood pressure (office) [ Time Frame: Change from baseline after one month of intervention ]
    Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)
  • Catecholamines (epinephrine) [ Time Frame: Change from baseline after one month of intervention ]
    24h urine samples will be collected and acidified with acetic acid, stored at -20°C until analysis. Catecholamines (epinephrine, norepinephrine, and dopamine) will be measured in one milliliter of urine by high-performance liquid chromatography with electrochemical detection (Coularray Detector, ESA Dionex, Chelmsford, USA).
  • Norepinephrine) [ Time Frame: Change from baseline after one month of intervention ]
    24h urine samples will be collected and acidified with acetic acid, stored at -20°C until analysis. Catecholamines (epinephrine, norepinephrine, and dopamine) will be measured in one milliliter of urine by high-performance liquid chromatography with electrochemical detection (Coularray Detector, ESA Dionex, Chelmsford, USA).
  • Dopamine (Catecholamine) [ Time Frame: Change from baseline after one month of intervention ]
    24h urine samples will be collected and acidified with acetic acid, stored at -20°C until analysis. Catecholamines (epinephrine, norepinephrine, and dopamine) will be measured in one milliliter of urine by high-performance liquid chromatography with electrochemical detection (Coularray Detector, ESA Dionex, Chelmsford, USA).
  • High-frequency component of Heart rate variability [ Time Frame: Change from baseline after one month of intervention ]
    We will use these mathematical methods to analyze a signal over time: temporal analysis, Fourier transformation and wavelet transformation. High-frequency (HF) translates fluctuations in parasympathetic activity to cardiac destination, modulated by ventilatory characteristics (frequency, courant volume).
  • Low frequency component of Heart rate variability [ Time Frame: Change from baseline after one month of intervention ]
    We will use these mathematical methods to analyze a signal over time: temporal analysis, Fourier transformation and wavelet transformation. Low frequency (LF) is classically considered to reflect the activity of the sympathetic system rather than the parasympathetic system.
  • 24 hours Diastolic blood pressure change (AMBP) [ Time Frame: Change from baseline after one month of intervention ]
    ambulatory measurements over 24h
  • 24 hours Mean Blood pressure (AMBP) [ Time Frame: Change from baseline after one month of intervention ]
    ambulatory measurements over 24h
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decrease Obstructive Sleep Apnea (OSA) Sympathetic Tone : Impact of APAP vs CPAP
Official Title  ICMJE Decrease in Sympathetic Tone in OSA Patients: Is CPAP More Effective Than APAP ?
Brief Summary The present study aims to compare muscle sympathetic neural activity by microneurography after one month treatment of fixed versus auto-adjusting CPAP treatment and its impact on arterial blood pressure
Detailed Description

Background: Sleep apnea syndrome (SAS) currently affects 10% of general population. It is characterized by the occurrence during the sleep of the upper airways closure which cause repeated asphyxia. It is a public health problem due to its cardiometabolic complications. Indeed, the absence of SAS treatment increases cardiovascular mortality by 12% at 10 years.

The main physiopathological mechanism is the activation of cardiovascular sympathetic control (the short-term regulation of blood pressure which bring in the sympathetic nervous system) An exposure to intermittent chronic hypoxia (caused by SAS) bring an increased of muscle sympathetic nerve activity (MSNA) contributing to elevated blood pressure Continuous Positive Airway Pressure (CPAP) can partly reduce this risk by decreasing elevation of blood pressure caused by the SAS. It has recently been demonstrated that all CPAP devices are not equivalent. Indeed, the auto-adjusted CPAP treatment induces a reduction in blood pressure lower than the reference treatment fixed CPAP.

To this extent it is interesting to conduct a new randomized trial comparing these two treatments with vascular sympathetic tone. This will be assessed by peroneal microneurography recording.

Objective: Compare Muscle Sympathetic Neural Activity (MSNA) by microneurography after one month of fixed versus auto-adjusted CPAP treatment in OSA patients naive from pressure therapy Methods: Prospective study, single-site, randomized, double-blind, parallel, one month controlled trial. After the diagnosis of sleep apnea, patients will be randomized for one month treatment with fixed ou auto-adjusting CPAP. Measurements of MSNA, heart rate variability and catecholamines will be held before and after treatment.

An interim analysis will be performed after the inclusion of 24 patients based on group sequential design

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Sleep Apnea Syndromes
Intervention  ICMJE
  • Device: Fixed CPAP
    CPAP is a device that applies continous fixed positive pressure to the airways in order to keep them opened during sleep
  • Device: Auto-adjusting CPAP
    Auto-adjusting CPAP is a device that applies auto-adjusting continous positive pressure to the airways in order to keep them opened during sleep
Study Arms  ICMJE
  • Experimental: Fixed CPAP
    CPAP always deliver air with the same pressure
    Intervention: Device: Fixed CPAP
  • Active Comparator: Auto-adjusting CPAP
    Auto-CPAP changes the pressure delivered depending on events detected at any time (apnea, hypopnea …) and applies the lowest pressure required to eliminate events.
    Intervention: Device: Auto-adjusting CPAP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2018)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2019
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patient with OSA (AHI ≥20 / h)
  • patient with daytime sleepiness
  • naive of any pressure treatment of OSA
  • patient able to provide written informed consent
  • not a vulnerable person or legally protected adult.

Exclusion Criteria:

  • pregnancy
  • Person deprived of liberty or subject to a legal protection measure.
  • Patient with serious heart failure (According to investigator judgment)
  • patient with central sleep apnea index above 20% of AHI
  • Patient with a significant intercurrent pathology that can influence the results. (According to investigator judgment).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Peeters, MD, PhD +33476762965 mpeeters@chu-grenoble.fr
Contact: Erika Treptow, MD, PhD +33664822293 erikatpw@hotmail.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03428516
Other Study ID Numbers  ICMJE 2017-A02937-46
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • ResMed
  • Agir pour les maladies chroniques
Investigators  ICMJE
Principal Investigator: Renaud Tamisier, MD, PhD University Grenoble Alps
PRS Account University Hospital, Grenoble
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP