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Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.

NCT ID: NCT03651648

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-18

Study Completion Date

2024-07-02

Brief Summary

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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

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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

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Apnea of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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SENSITACT System ON

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

Group Type EXPERIMENTAL

SENSITACT System

Intervention Type DEVICE

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 System OFF

The SENSITACT controller doesnt send any trigger signal to the PASITHEA stimulator even if an early sign of an apnea-bradycardia is detected.

Group Type SHAM_COMPARATOR

SENSITACT System

Intervention Type DEVICE

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).

Interventions

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SENSITACT System

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).

Intervention Type DEVICE

SENSITACT System

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).

Intervention Type DEVICE

Other Intervention Names

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Actived stimulation desactivated stimulation

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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,
* 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).
Minimum Eligible Age

34 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick PLADYS, Pr

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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CHU de Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick PLADYS, Pr

Role: CONTACT

[email protected]
06 34 19 11 30

Facility Contacts

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Patrick PLADYS, Pr

Role: primary

[email protected]

Other Identifiers

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35RC16_9894_SENSITACT

Identifier Type: -

Identifier Source: org_study_id