Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04343924 |
Other study ID # |
19-PP-12 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 7, 2023 |
Est. completion date |
October 20, 2023 |
Study information
Verified date |
January 2024 |
Source |
Centre Hospitalier Universitaire de Nice |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Post-traumatic stress disorder (PTSD) is a set of symptoms that can be developed as a result
of exposure to a traumatic event or events that can range in prevalence from 25% to 75%.
While therapeutic management combines psychotherapy, drug therapy and social support, some
PTSD remain resistant after early and appropriate initial treatment. In terms of
physiopathology, several studies have shown that parasympathetic activity is significantly
decreased in patients with PTSD. In scuba diving, the cardio-vascular stresses associated
with submersion of the subject and the lungs due to breathing in a regulator are at the
origin of a reflex activation of the parasympathetic nervous system. The objective is to
study the effects of the scuba diving activities-induced autonomic parasympathetic nervous
system activation on the symptomatic progression of patients with PTSD.
The study population will consist of patients monitored and treated for PTSD following the
attacks of 14/07/2016 in Nice (France).
Description:
A group will be composed of patients (n=12) who will complete a Scuba Diving Discovery Course
(GP+ Diving Group). This course, lasting 2 weeks, will consist of a daily dive, 5 days per
week, for a total of 10 dives. These will be supervised by a graduate instructor according to
the rules of supervision defined by the sport code. The dives will be conducted in open air,
at a maximum depth of 6 meters for a maximum duration of 20 minutes.
A matched group (gender, age, height, weight and BMI) will be composed of patients (n=12) who
will not complete the Scuba Diving Discovery Course (GP- Virtual reality group). The subjects
of this group will follow virtual reality sessions recreating the environment in which the
scuba divers of the GP+ group operate. A control group (GT) will be composed of patients
(n=12) who are monitored and treated for PTSD and who will not attend the dive discovery
course or virtual reality sessions.
- The main evaluation criterion will be the NON-INVASIVE determination of salivary alpha
amylase.
- Secondary evaluation criteria will be heart rate variation, CGI, HAD and BECK Anxiety,
EGF, PCL-S and IES questionary.
The main objective is to study the effects of immersion and pressure relief ventilation on
the activation of the autonomic parasympathetic nervous system.
Secondary objectives are to assess the symptomatic impact of parasympathetic autonomic
nervous system activation on overall improvement, anxiety and depressive symptoms,
functioning, and the 3 subtypes of PTSD symptoms as vegetative neuro hyperactivity, invasive
syndrome and avoiding