Apnea of PrematuritySENSITACTNCT03651648
Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.
A study testing SENSITACT System in people with Apnea of Prematurity, run by Rennes University Hospital at 1 site in France.
Trial summary
The goal of the SENSITACT system is to activate an adaptive kinesthetic stimulation to treat apnea-bradycardia events on preterm infants, while minimizing deleterious effects, in particular arousals that can be due either to respiratory efforts or to kinesthetic stimulation itself. Read more about this study
- Who is it for?
- Ages 34 to 36 weeks
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- SENSITACT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2019to 18 Jan 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 34 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- written informed consent,
- Premature infants,
- born to a term less than 34 weeks of amenorrhea (AS),
- Age less than 36 weeks post-menstrual age,
- With a postnatal age greater than 4 days,
- caffeine treated, for at least 36 hours,
- Presenting episodes of bradycardia apnea significant (>10 sec with bradycardia <100 bpm or SaO2<80%) with an interval of less than 6 hours between two episodes observed in the 24 hours preceding inclusion.
Who cannot join
- Major congenital neurological abnormalities,
- Congenital abnormalities of the respiratory tracts,
- HIV grade 3 or 4,
- Periventricular leukomalacia,
- Invasive ventilation and non-invasive ventilation in NAVA mode,
- Cyanogenic malformative heart disease,
Show all 9Show fewer
- Sepsis diagnosed in the 4 days prior to registration (CRP> 10mg / L),
- maternal addiction during pregnancy,
- Father and / or mother legally protected (under judicial protection, guardianship or supervision).
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the SENSITACT system is to activate an adaptive kinesthetic stimulation to treat apnea-bradycardia events on preterm infants, while minimizing deleterious effects, in particular arousals that can be due either to respiratory efforts or to kinesthetic stimulation itself. This novel system will provide an alternative treatment to apnea-bradycardia, with improved patient comfort and autonomy. In particular, it may become a complementary solution for the current treatments (Manual stimulation by caregivers, continuous or intermittent nasal positive pressure ventilation and methylxanthine therapies) that do not appear to be optimal and usually only allow a partial reduction in the number and severity of apneas.
Read the detailed description
The main hypothesis behind the SENSITACT system is that kinesthetic stimulation can terminate apneas-bradycardias with minimal patient arousal. The aim is to stimulate mechanoreceptors through the skin by kinesthetic stimulation on the lower abdominal zone. This is a region of the body that is covered with Pacinian corpuscles, a very sensitive kind of mechanoreceptors, which respond to rapid vibrations on the skin (200-300 Hz). Vibro-tactile stimulation of these mechano-receptors will trigger a reaction typical of the startle reflex. This reflex causes 1) an immediate myotonic reaction and 2) a widespread autonomic response. The former should have a direct effect on obstructive respiratory disorders with an increase in chin muscle tones within 80 to 100 ms. The latter should act on central respiratory disorders, with activation of the sympathetic nervous system. Since both responses are mediated via sub-cortical nervous center, it is expected that patient arousal will be limited. Preliminary clinical studies on adult patients conducted by LTSI, Sorin CRM and CHU de Grenoble (Skin\&SAS, HYPNOS, EKINOx), that have used the same PASITHEA stimulation device have confirmed activation of the sympathetic nervous system and a significant reduction in the duration of apnea or hypopnea events, while no differences were observed on patients' sleep architecture.
The SENSITACT system is able to detect apneas-bradycardias in real-time, so that kinesthetic stimulation can be triggered to stop respiratory disorders very early during the event. Detection is performed within the SENSITACT controller station that receives data from all sensors connected to the Patient Monitor in real-time. As soon as the early signs of an apnea-bradycardia are detected, the SENSITACT controller sends a trigger signal to the PASITHEA stimulator that immediately activates kinesthetic stimulation.
Kinesthetic stimulation is stopped when a normal condition (normal cardiac rhythm) is detected or when a maximum number of stimulation pulses have been reached.
- Conditions
- Apnea of Prematurity
- Being tested
- SENSITACT System
- Keywords
- apnea; prematurity; kinesthetic stimulation
- Medical subject headings
- Apnea, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSITACT SystemDevice
Also called Actived stimulation
the activated stimulation (ON period of 6 hours) will be hidden from the care team, who will continue the care according to the usual procedures (blind treatment).
SENSITACT SystemDevice
Also called desactivated stimulation
the desactivated stimulation (OFF period of 6 hours) will be hidden from the care team, who will continue the care according to the usual procedures (blind treatment).
| Study group | Role | What they receive |
|---|---|---|
| SENSITACT System ON | Experimental | As soon as the early signs of an apnea-bradycardia are detected, the SENSITACT controller sends a trigger signal to the PASITHEA stimulator that immediately activates kinesthetic stimulation Receives: Device: SENSITACT System |
| SENSITACT System OFF | Sham comparator | The SENSITACT controller doesnt send any trigger signal to the PASITHEA stimulator even if an early sign of an apnea-bradycardia is detected. Receives: Device: SENSITACT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative duration of apnea-bradycardia
Cumulative duration of apnea-bradycardia over a period of 6 hours with stimulation activated or not.
Measured: 12 hours (H12)
Secondary outcomes (6)
Distribution of bradycardia durations
A bradycardia is defined by an acute event lasting at least 5 seconds with a decrease in heart rate of more than 33% of the basal heart rate (median of heart measured on 5-min stationary periods during quiet sleep).
The distribution of the durations will be quantified in terms of median, IQR and distribution curve
Measured: 12 hours (H12)
Depth of bradycardia
A bradycardia is defined by an acute event lasting at least 5 seconds with a decrease in heart rate of more than 33% of the basal heart rate (median of heart measured on 5-min stationary periods during quiet sleep).
The depth of bradycardia will be measured by the area under the curve with the upper limit of the curve defined by the value of "basal heart rate-33%" and expressed in beats/min*sec The distribution of the depth of bradycardias will be quantified in terms of median, IQR and distribution curve
Measured: 12 hours (H12)
Depth of desaturations
The depth of desaturation will be measured by the area under the curve with the upper limit of the curve set at a Saturation of 80% The distribution of the depth of desaturations will be quantified in terms of median, IQR and distribution curve
Measured: 12 hours (H12)
Caregiver interventions
The number of caregiver interventions associated with a cardio-respiatory event will be quantified and expressed in number/hour
Measured: 12 hours (H12)
Cardiorespiratory parameters in response to stimulation
The delay between the initiation of stimulation and the first breath will be measured and expressed in median IQR The delay between the initiation of stimulation and the normalization of heart rate above the limit of "basal heart rate-33%" will be measured and expressed in median IQR The delay between the initiation of stimulation and the observation of a Saturation above 80% will be measured and expressed in median IQR
Measured: 6 hours (H6)
Premature's sleep-wake cycles
Duration of the stages identified
Measured: 12 hours (H12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start24 Oct 2019
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick PLADYS, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651648
- Sponsor's protocol ID
- 35RC16_9894_SENSITACT
- Acronym
- SENSITACT
- Status last verified
- Mar 2026
- First submitted
- 18 Jul 2018
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.
- ClinicalTrials.gov ID
- NCT03651648
- Acronym / sponsor ID
- SENSITACT / 35RC16_9894_SENSITACT
- Conditions
- Apnea of Prematurity
- Keywords
- apnea; prematurity; kinesthetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 29 Aug 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 goal of the SENSITACT system is to activate an adaptive kinesthetic stimulation to treat apnea-bradycardia events on preterm infants, while minimizing deleterious effects, in particular arousals that can be due either to respiratory efforts or to kinesthetic stimulation itself. This novel system will provide an alternative treatment to apnea-bradycardia, with improved patient comfort and autonomy. In particular, it may become a complementary solution for the current treatments (Manual stimulation by caregivers, continuous or intermittent nasal positive pressure ventilation and methylxanthine therapies) that do not appear to be optimal and usually only allow a partial reduction in the number and severity of apneas.
Detailed description
The main hypothesis behind the SENSITACT system is that kinesthetic stimulation can terminate apneas-bradycardias with minimal patient arousal. The aim is to stimulate mechanoreceptors through the skin by kinesthetic stimulation on the lower abdominal zone. This is a region of the body that is covered with Pacinian corpuscles, a very sensitive kind of mechanoreceptors, which respond to rapid vibrations on the skin (200-300 Hz). Vibro-tactile stimulation of these mechano-receptors will trigger a reaction typical of the startle reflex. This reflex causes 1) an immediate myotonic reaction and 2) a widespread autonomic response. The former should have a direct effect on obstructive respiratory disorders with an increase in chin muscle tones within 80 to 100 ms. The latter should act on central respiratory disorders, with activation of the sympathetic nervous system. Since both responses are mediated via sub-cortical nervous center, it is expected that patient arousal will be limited. Preliminary clinical studies on adult patients conducted by LTSI, Sorin CRM and CHU de Grenoble (Skin\&SAS, HYPNOS, EKINOx), that have used the same PASITHEA stimulation device have confirmed activation of the sympathetic nervous system and a significant reduction in the duration of apnea or hypopnea events, while no differences were observed on patients' sleep architecture.
The SENSITACT system is able to detect apneas-bradycardias in real-time, so that kinesthetic stimulation can be triggered to stop respiratory disorders very early during the event. Detection is performed within the SENSITACT controller station that receives data from all sensors connected to the Patient Monitor in real-time. As soon as the early signs of an apnea-bradycardia are detected, the SENSITACT controller sends a trigger signal to the PASITHEA stimulator that immediately activates kinesthetic stimulation.
Kinesthetic stimulation is stopped when a normal condition (normal cardiac rhythm) is detected or when a maximum number of stimulation pulses have been reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SENSITACT System ON | Experimental | Device: SENSITACT SystemAs soon as the early signs of an apnea-bradycardia are detected, the SENSITACT controller sends a trigger signal to the PASITHEA stimulator that immediately activates kinesthetic stimulation |
| SENSITACT System OFF | Sham comparator | Device: SENSITACT SystemThe SENSITACT controller doesnt send any trigger signal to the PASITHEA stimulator even if an early sign of an apnea-bradycardia is detected. |
Who may qualify
- Ages
- 34 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- written informed consent,
- Premature infants,
Key exclusion criteria (9 listed)
- Major congenital neurological abnormalities,
- Congenital abnormalities of the respiratory tracts,
- HIV grade 3 or 4,
- Periventricular leukomalacia,
- Invasive ventilation and non-invasive ventilation in NAVA mode,
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 |
|---|---|---|
| SENSITACT SystemAlso: Actived stimulationthe activated stimulation (ON period of 6 hours) will be hidden from the care team, who will continue the care according to the usual procedures (blind treatment). | Device | SENSITACT System ON |
| SENSITACT SystemAlso: desactivated stimulationthe desactivated stimulation (OFF period of 6 hours) will be hidden from the care team, who will continue the care according to the usual procedures (blind treatment). | Device | SENSITACT System OFF |
Primary outcome
Cumulative duration of apnea-bradycardia
Time frame: 12 hours (H12)
Cumulative duration of apnea-bradycardia over a period of 6 hours with stimulation activated or not.
6 secondary outcomes
Distribution of bradycardia durations
Time frame: 12 hours (H12)
Depth of bradycardia
Time frame: 12 hours (H12)
Depth of desaturations
Time frame: 12 hours (H12)
Caregiver interventions
Time frame: 12 hours (H12)
Cardiorespiratory parameters in response to stimulation
Time frame: 6 hours (H6)
Premature's sleep-wake cycles
Time frame: 12 hours (H12)
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 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Apnea of Prematurity
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
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Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
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Automated Apnoea Detection in Preterms on Non-invasive Ventilation
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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.
Patrick PLADYS, Pr principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSITACT System in people with Apnea of Prematurity, run by Rennes University Hospital 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 7 inclusion and 9 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 30 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
Cumulative duration of apnea-bradycardia (time frame: 12 hours (H12)). 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 30 Mar 2026.