Sleep Apnea Syndromes
Conditions
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. Assuming an α error of 5%, a statistical power of 80%, and a unilateral situation : 34 patients per arm will be needed to be enrolled in the study. The enrollment target for the study will be reviewed and may be refined following the study interim analysis and taking account 20% of study drop-out.
Interventions
DEVICEFixed CPAP
CPAP is a device that applies continous fixed positive pressure to the airways in order to keep them opened during sleep
DEVICEAuto-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
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
ResMed
Agir pour les maladies chroniques
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sympathetic tone (MSNA) | Change from baseline after one month of intervention | Change from Baseline Sympathetic tone at 1 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood pressure (office) | 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 | 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) | 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) | 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 from ESA- Dionex, Chelmsford, USA). |
| Norepinephrine) | 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 from ESA- Dionex, Chelmsford, USA). |
| 24 hours Systolic Blood pressure (AMBP) | Change from baseline after one month of intervention | Change from Baseline in 24 hours ambulatory systolic blood pressure |
| High-frequency component of Heart rate variability | 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 | 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) | Change from baseline after one month of intervention | ambulatory measurements over 24h |
| 24 hours Mean Blood pressure (AMBP) | Change from baseline after one month of intervention | ambulatory measurements over 24h |
| Dopamine (Catecholamine) | 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 from ESA- Dionex, Chelmsford, USA). |
Countries
France
Outcome results
None listed