Sleep Apnea SyndromesAPAP-CPAPNCT03428516
Decrease Obstructive Sleep Apnea (OSA) Sympathetic Tone : Impact of APAP vs CPAP
A study testing Fixed CPAP and Auto-adjusting CPAP in people with Sleep Apnea Syndromes, run by University Hospital, Grenoble at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Fixed CPAP and Auto-adjusting CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decrease in Sympathetic Tone in OSA Patients: Is CPAP More Effective Than APAP ?
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
Read the 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.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Fixed CPAP, Auto-adjusting CPAP
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed CPAPDevice
CPAP is a device that applies continous fixed positive pressure to the airways in order to keep them opened during sleep
Auto-adjusting CPAPDevice
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 group | Role | What they receive |
|---|---|---|
| Fixed CPAP | Experimental | CPAP always deliver air with the same pressure Receives: Device: Fixed CPAP |
| Auto-adjusting CPAP | Active comparator | Auto-CPAP changes the pressure delivered depending on events detected at any time (apnea, hypopnea …) and applies the lowest pressure required to eliminate events. Receives: Device: Auto-adjusting CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic tone (MSNA)
Change from Baseline Sympathetic tone at 1 months
Measured: Change from baseline after one month of intervention
Secondary outcomes (11)
24 hours Systolic Blood pressure (AMBP)
Change from Baseline in 24 hours ambulatory systolic blood pressure
Measured: Change from baseline after one month of intervention
Systolic Blood pressure (office)
Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)
Measured: Change from baseline after one month of intervention
Diastolic Blood pressure (office) change after 1 month
Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)
Measured: Change from baseline after one month of intervention
Mean Blood pressure (office)
Clinical BP on 3 occasions, SBP and BP will be assessed. Mean BP calculated as DBP+1/3(SBP-DBP)
Measured: Change from baseline after one month of intervention
Catecholamines (epinephrine)
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).
Measured: Change from baseline after one month of intervention
Norepinephrine)
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).
Measured: Change from baseline after one month of intervention
Dopamine (Catecholamine)
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).
Measured: Change from baseline after one month of intervention
High-frequency component of Heart rate variability
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).
Measured: Change from baseline after one month of intervention
Low frequency component of Heart rate variability
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.
Measured: Change from baseline after one month of intervention
24 hours Diastolic blood pressure change (AMBP)
ambulatory measurements over 24h
Measured: Change from baseline after one month of intervention
24 hours Mean Blood pressure (AMBP)
ambulatory measurements over 24h
Measured: Change from baseline after one month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Mar 2018
- Primary completion17 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., ResMed, Agir pour les maladies chroniques
- Responsible party
- Sponsor
- Investigators
- Renaud Tamisier, MD, PhD, Principal investigator, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428516
- Sponsor's protocol ID
- 2017-A02937-46
- Acronym
- APAP-CPAP
- Status last verified
- Jul 2022
- First submitted
- 17 Jan 2018
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pepin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Levy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.
PubMed 27091542Treptow E, Pepin JL, Bailly S, Levy P, Bosc C, Destors M, Woehrle H, Tamisier R. Reduction in sympathetic tone in patients with obstructive sleep apnoea: is fixed CPAP more effective than APAP? A randomised, parallel trial protocol. BMJ Open. 2019 Apr 4;9(4):e024253. doi: 10.1136/bmjopen-2018-024253.
PubMed 30948567
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decrease in Sympathetic Tone in OSA Patients: Is CPAP More Effective Than APAP ?
- ClinicalTrials.gov ID
- NCT03428516
- Acronym / sponsor ID
- APAP-CPAP / 2017-A02937-46
- Conditions
- Sleep Apnea Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., ResMed, Agir pour les maladies chroniques
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed CPAP | Experimental | Device: Fixed CPAPCPAP always deliver air with the same pressure |
| Auto-adjusting CPAP | Active comparator | Device: Auto-adjusting CPAPAuto-CPAP changes the pressure delivered depending on events detected at any time (apnea, hypopnea …) and applies the lowest pressure required to eliminate events. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed CPAPCPAP is a device that applies continous fixed positive pressure to the airways in order to keep them opened during sleep | Device | Fixed CPAP |
| Auto-adjusting CPAPAuto-adjusting CPAP is a device that applies auto-adjusting continous positive pressure to the airways in order to keep them opened during sleep | Device | Auto-adjusting CPAP |
Primary outcome
Sympathetic tone (MSNA)
Time frame: Change from baseline after one month of intervention
Change from Baseline Sympathetic tone at 1 months
11 secondary outcomes
24 hours Systolic Blood pressure (AMBP)
Time frame: Change from baseline after one month of intervention
Systolic Blood pressure (office)
Time frame: Change from baseline after one month of intervention
Diastolic Blood pressure (office) change after 1 month
Time frame: Change from baseline after one month of intervention
Mean Blood pressure (office)
Time frame: Change from baseline after one month of intervention
Catecholamines (epinephrine)
Time frame: Change from baseline after one month of intervention
Norepinephrine)
Time frame: Change from baseline after one month of intervention
Dopamine (Catecholamine)
Time frame: Change from baseline after one month of intervention
High-frequency component of Heart rate variability
Time frame: Change from baseline after one month of intervention
Low frequency component of Heart rate variability
Time frame: Change from baseline after one month of intervention
24 hours Diastolic blood pressure change (AMBP)
Time frame: Change from baseline after one month of intervention
24 hours Mean Blood pressure (AMBP)
Time frame: Change from baseline after one month of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 27091542Pepin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Levy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.
- Derived from this study: PubMed 30948567Treptow E, Pepin JL, Bailly S, Levy P, Bosc C, Destors M, Woehrle H, Tamisier R. Reduction in sympathetic tone in patients with obstructive sleep apnoea: is fixed CPAP more effective than APAP? A randomised, parallel trial protocol. BMJ Open. 2019 Apr 4;9(4):e024253. doi: 10.1136/bmjopen-2018-024253.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud Tamisier, MD, PhD principal investigator
University Grenoble Alps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed CPAP and Auto-adjusting CPAP in people with Sleep Apnea Syndromes, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic tone (MSNA) (time frame: Change from baseline after one month of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03428516, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.