NCT03651648

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 24, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

July 18, 2018

Last Update Submit

March 27, 2026

Conditions

Apnea of Prematurity

Keywords

apnea; prematurity; kinesthetic stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Distribution of bradycardia durations

    12 hours (H12)

  • Depth of bradycardia

    12 hours (H12)

  • Depth of desaturations

    12 hours (H12)

  • Caregiver interventions

    12 hours (H12)

  • Cardiorespiratory parameters in response to stimulation

    6 hours (H6)

  • +1 more secondary outcomes

Study Arms (2)

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

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.

Device: SENSITACT System

Interventions

SENSITACT SystemDEVICE

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).

Also known as: Actived stimulation
SENSITACT System ON

Eligibility Criteria

Age34 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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,

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35200, France

Location

MeSH Terms

Conditions

ApneaPremature Birth

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Patrick PLADYS, Pr

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 29, 2018

Study Start

October 24, 2019

Primary Completion

January 18, 2022

Study Completion

January 18, 2022

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)