NCT05771909: DIAL_X

Effect of App-driven Deep Breathing (NEURODIGITX) on Anxiety Levels and Quality of Life in Caregivers

Withdrawn NA Last updated 19 August 2025

What this trial tests

NA trial testing NeurodigitX in Anxiety Disorders. Withdrawn.

Timeline

30 November 2023

Primary endpoint
29 November 2024

31 December 2024

Quick facts

Lead sponsor	Fondation Hôpital Saint-Joseph
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Start date	30 November 2023
Primary completion	29 November 2024
Estimated completion	31 December 2024
Sites	4 locations across France

Drugs / interventions tested

• NeurodigitX
• Control

Conditions studied

• Anxiety Disorders — all drugs for Anxiety Disorders →
• Hospital Workers — all drugs for Hospital Workers →
• Deep Breath — all drugs for Deep Breath →

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

18 and older, any sex, with Anxiety Disorders or Hospital Workers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The occurrence of the COVID-19 pandemic is associated with an increase in psychiatric illnesses (depression, anxiety) in the general population due to the infectious and vital risk involved, changes in social structure, particularly in the family environment, episodes of confinement, and even professional instability. These international phenomena have also been observed in France.

In addition to the constraints of the general population, health care workers have been, and continue to be, subject to other forms of constraints, linked to their professional activity. Indeed, the risk of viral exposure is for them major, the confrontation with the deaths of patients because of their fragility or the weakness of the care structures, are more violent in connection with their immediate reality. In addition, the workload due to health imperatives has also led to physical and psychological exhaustion of the health care teams. In addition to the international evidence, the existence and severity of the psychological consequences for health care workers have recently been documented at the local level in a survey conducted among the staff of the Groupe hospitalier Paris Saint-Joseph (GhPSJ). In this study of more than 780 people, nearly half of whom were in charge of patients infected with SARS-CoV2, 62% reported increased anxiety since the beginning of the epidemic, 41% had symptoms of anxiety, 21% had symptoms of depression and 14% had signs of post-traumatic stress. Approximately 25% of the total population had chosen to make regular use of the "bulle" (a decompression and care platform made available to staff since the first wave within the establishment) with the aim of reducing the anxiety generated by the situation and particularly by their professional activity. Given the importance of anxiety symptoms detected in healthcare professionals during the COVID-19 pandemic, the use of a simple, brief technique, requiring neither trained personnel nor expensive or difficult-to-access devices, aimed at reducing anxious stress could be of significant benefit to the population, especially to caregivers.

The objective of this study is to measure the effect of deep breathing on the anxiety of health professionals in the aftermath of the COVID-19 pandemic, and its effect on their quality of life. In order to measure the quality of the sessions, the breathing movements will be performed using a calibrated program and their immediate effectiveness will be evaluated by the variation of the heart rate, visible just after the program by the user.

The NeurodigitX® system offers to control interactive 3D games on a smartphone application through breath via a sensor connected to the phone by Bluetooth. This tool also allows to measure by plethysmography the heart rate variability in a simple and non-invasive way.

This system has been created as a preventive health solution by allowing everyone to measure, compare and share the activity of their Autonomic Nervous System (ANS) to better predict, understand, prevent and treat certain chronic diseases.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.