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

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.

Study Overview

• Status: Recruiting
• Conditions: Apnea of Prematurity
• Intervention / Treatment: Device: SENSITACT System; Device: SENSITACT System

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick PLADYS, Pr; Phone Number: 06 34 19 11 30; Email: patrick.pladys@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35200
    • Recruiting
    • CHU de Rennes
    • Contact: Patrick PLADYS, Pr; Email: patrick.pladys@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 7 months (Child)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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).; Other Names: Actived stimulation; 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).; Other Names: desactivated stimulation
Sham Comparator: 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.	Device: 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).; Other Names: Actived stimulation; 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).; Other Names: desactivated stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative duration of apnea-bradycardia	Cumulative duration of apnea-bradycardia over a period of 6 hours with stimulation activated or not.	12 hours (H12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	12 hours (H12)
Caregiver interventions	The number of caregiver interventions associated with a cardio-respiatory event will be quantified and expressed in number/hour	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	6 hours (H6)
Premature's sleep-wake cycles	Duration of the stages identified	12 hours (H12)

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Patrick PLADYS, Pr, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Estimated): January 2, 2024
• Study Completion (Estimated): July 2, 2024

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: apnea; prematurity; kinesthetic stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Arrhythmias, Cardiac; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Apnea; Premature Birth; Bradycardia
• Other Study ID Numbers: 35RC16_9894_SENSITACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No