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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03651648
Other study ID # 35RC16_9894_SENSITACT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 18, 2019
Est. completion date July 2, 2024

Study information

Verified date November 2023
Source Rennes University Hospital
Contact Patrick PLADYS, Pr
Phone 06 34 19 11 30
Email patrick.pladys@chu-rennes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
France CHU de Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary Caregiver interventions The number of caregiver interventions associated with a cardio-respiatory event will be quantified and expressed in number/hour 12 hours (H12)
Secondary 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)
Secondary Premature's sleep-wake cycles Duration of the stages identified 12 hours (H12)
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