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

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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

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

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: Fixed CPAP Device: Auto-adjusting CPAP Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Decrease in Sympathetic Tone in OSA Patients: Is CPAP More Effective Than APAP ?
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Fixed CPAP
CPAP always deliver air with the same pressure
Device: Fixed CPAP
CPAP is a device that applies continous fixed positive pressure to the airways in order to keep them opened during sleep

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.
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




Primary Outcome Measures :
  1. Sympathetic tone (MSNA) [ Time Frame: Change from baseline after one month of intervention ]
    Change from Baseline Sympathetic tone at 1 months


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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).

  6. 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).

  7. 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).

  8. 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).


  9. 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.


  10. 24 hours Diastolic blood pressure change (AMBP) [ Time Frame: Change from baseline after one month of intervention ]
    ambulatory measurements over 24h

  11. 24 hours Mean Blood pressure (AMBP) [ Time Frame: Change from baseline after one month of intervention ]
    ambulatory measurements over 24h



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428516


Contacts
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Contact: Marie Peeters, MD, PhD +33476762965 mpeeters@chu-grenoble.fr
Contact: Erika Treptow, MD, PhD +33664822293 erikatpw@hotmail.com

Locations
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France
CHU Grenoble Alpes Recruiting
Grenoble, France, 38000
Contact: Renaud Tamisier         
Sponsors and Collaborators
University Hospital, Grenoble
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
ResMed
Agir pour les maladies chroniques
Investigators
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Principal Investigator: Renaud Tamisier, MD, PhD University Grenoble Alps

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03428516     History of Changes
Other Study ID Numbers: 2017-A02937-46
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases