HealthySOMNO-BRSNCT02650232
Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity
A study testing SOMNOtouch device (Somnomedics), Orthostatic test and Finapres Nova device (FMS system) in people with Healthy and Heart Failure, run by University Hospital, Angers at 2 sites in France.
Trial summary
To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the baroreflex. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Heart Failure
- What is being tested?
- SOMNOtouch device (Somnomedics), Orthostatic test and Finapres Nova device (FMS system)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2015to Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good health
- normal ECG
- cardiac ejection fraction > 50%
- clinically sable
- with sinusal heart rhythm
- without sign of neuropathy
- cardiac ejection fraction < 50%
Who cannot join
- with chronic disease or treatment
- under law protection
- not affiliated to the national health insurance
- For patients with heart failure
- with pace maker
- under law protection
- not affiliated to the national health insurance
- skin lesion or severe allergia
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU d'Angers
Angers, Maine Et Loire, 49000
CH de Cholet
Cholet, Maine Et Loire, 49325
About this study
Official title: Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity in Healthy Subjects and in Patients With Heart Failure
To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the baroreflex. A good correlation for measuring the baroreflex sensitivity between the system "SOMNOtouch" and digital photoplethysmography as a reference method is expected but should be evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects with heart failure. We will also evaluate the feasibility of measuring the baroreflex sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance test.
- Conditions
- Healthy, Heart Failure
- Being tested
- SOMNOtouch device (Somnomedics), Orthostatic test, Finapres Nova device (FMS system)
- Keywords
- Volunteers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOMNOtouch device (Somnomedics)Device
In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)
Orthostatic testProcedure or surgery
For each arm we will proceed to an orthostatic test day one and day two with :
- 10 minutes in supine position
- 10 minutes in sitting position
- 5 minutes in standing position
- 5 minutes in supine position
Finapres Nova device (FMS system)Device
| Study group | Role | What they receive |
|---|---|---|
| Young Healthy Volunteers | Other | We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity Receives: Device: SOMNOtouch device (Somnomedics); Procedure: Orthostatic test; Device: Finapres Nova device (FMS system) |
| Old Healthy Volunteers | Other | We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity Receives: Device: SOMNOtouch device (Somnomedics); Procedure: Orthostatic test; Device: Finapres Nova device (FMS system) |
| Patients with heart failure | Other | We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity Receives: Device: SOMNOtouch device (Somnomedics); Procedure: Orthostatic test; Device: Finapres Nova device (FMS system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of correlation in baroreflex sensitivity measurements between SOMNOTOUCH and FINAPRES nova during the orthostatic test
baroreflex sensitivity is measured by comparison of the variations in heart rate and in blood pressure (baroreflexe slope method \& fransfer function method). We will compare this baroreflex sensitivity obtained from SOMNOTOUCH measurement and from Finapres nova measurements (coefficient of correlation)
Measured: Day one
Secondary outcomes (3)
Coefficient of correlation in baroreflex sensitivity measurements between day one and day two during the orthostatic test
baroreflex sensitivity is measured by comparison of the variations in heart rate and in blood pressure (baroreflex slope method \& fransfer function method). We will compare this baroreflex sensitivity between the two active orthostatic tests (coefficient of correlation).
Measured: Day two vs Day one
Duration of recordings in hours over 24 hours that allows the measurement of the spontaneous baroreflex sensitivity with the SOMNOTOUCH system
We will mesure over 24 hours the duration in hours when the measurement of the baroreflex sensitivity is possible taken in account the quality of the physiological signals.
Measured: Day one (24 hours)
Difference in the baroreflex sensitivity between Day & Night
We will compare the baroreflex sensitivity between day and night in each group and between groups.
Measured: Day one (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- LivaNova, SomnoMedics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650232
- Sponsor's protocol ID
- 15-A01215-44
- Acronym
- SOMNO-BRS
- Status last verified
- Jan 2020
- First submitted
- 21 Dec 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity in Healthy Subjects and in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02650232
- Acronym / sponsor ID
- SOMNO-BRS / 15-A01215-44
- Conditions
- Healthy, Heart Failure
- Keywords
- Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- LivaNova, SomnoMedics
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 8 Jan 2016 (estimated)
- 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.
To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the baroreflex. A good correlation for measuring the baroreflex sensitivity between the system "SOMNOtouch" and digital photoplethysmography as a reference method is expected but should be evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects with heart failure. We will also evaluate the feasibility of measuring the baroreflex sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance test.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young Healthy Volunteers | Other | Device: SOMNOtouch device (Somnomedics), Procedure: Orthostatic test, Device: Finapres Nova device (FMS system)We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity |
| Old Healthy Volunteers | Other | Device: SOMNOtouch device (Somnomedics), Procedure: Orthostatic test, Device: Finapres Nova device (FMS system)We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity |
| Patients with heart failure | Other | Device: SOMNOtouch device (Somnomedics), Procedure: Orthostatic test, Device: Finapres Nova device (FMS system)We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- good health
- normal ECG
- cardiac ejection fraction > 50%
- clinically sable
- with sinusal heart rhythm
Key exclusion criteria (8 listed)
- with chronic disease or treatment
- under law protection
- not affiliated to the national health insurance
- For patients with heart failure
- with pace maker
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 |
|---|---|---|
| SOMNOtouch device (Somnomedics)In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference) | Device | Old Healthy Volunteers, Patients with heart failure, Young Healthy Volunteers |
| Orthostatic testFor each arm we will proceed to an orthostatic test day one and day two with : * 10 minutes in supine position * 10 minutes in sitting position * 5 minutes in standing position * 5 minutes in supine position | Procedure or surgery | Old Healthy Volunteers, Patients with heart failure, Young Healthy Volunteers |
| Finapres Nova device (FMS system) | Device | Old Healthy Volunteers, Patients with heart failure, Young Healthy Volunteers |
Primary outcome
Coefficient of correlation in baroreflex sensitivity measurements between SOMNOTOUCH and FINAPRES nova during the orthostatic test
Time frame: Day one
baroreflex sensitivity is measured by comparison of the variations in heart rate and in blood pressure (baroreflexe slope method \& fransfer function method). We will compare this baroreflex sensitivity obtained from SOMNOTOUCH measurement and from Finapres nova measurements (coefficient of correlation)
3 secondary outcomes
Coefficient of correlation in baroreflex sensitivity measurements between day one and day two during the orthostatic test
Time frame: Day two vs Day one
Duration of recordings in hours over 24 hours that allows the measurement of the spontaneous baroreflex sensitivity with the SOMNOTOUCH system
Time frame: Day one (24 hours)
Difference in the baroreflex sensitivity between Day & Night
Time frame: Day one (24 hours)
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 7 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOMNOtouch device (Somnomedics), Orthostatic test and Finapres Nova device (FMS system) in people with Healthy and Heart Failure, run by University Hospital, Angers at 2 sites 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 7 inclusion and 8 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Coefficient of correlation in baroreflex sensitivity measurements between SOMNOTOUCH and FINAPRES nova during the orthostatic test (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2020.