Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04925830 |
| Other study ID # |
34_DT_Biofeedback |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 18, 2020 |
| Est. completion date |
June 17, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
University Hospital, Geneva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Inhibitory control refers to the conscious and voluntary suppression of predominant responses
when they are automatic, inappropriate, or incorrect. Inhibitory control plays a key role in
self-regulation and self-control behaviors in many different areas of everyday life. During
aging, their decline would impact executive functioning and mental health.
Recently, physiological training methods including heart rate variability biofeedback
(HRV-BF), based on heart rate and respiration measurements, and hemoencephalography
biofeedback (nirHEG NF), based on the hemodynamic response of some prefrontal regions, have
proven to have a positive impact on executive functions. In this study, subjects of the
experimental group were exposed to biofeedback training during 10 sessions, once a week, and
their results compared to those of the control group, which did not receive biofeedback
training.
This study aims to explore the impact of training that combines two innovative techniques,
such as heart rate variability biofeedback and hemoencephalography biofeedback on the
inhibitory control of older adults. We expect positive effects of biofeedback training on the
inhibition tasks and the targeted physiological parameters.
Primary objective - We intend to demonstrate that heart rate variability biofeedback training
coupled with hemoencephalography biofeedback training can be effective methods to counteract
the decline of inhibitory control in older adults.
Secondary objective - We intend to demonstrate that heart rate variability biofeedback and
hemoencephalography biofeedback can effectively increase heart rate variability and blood
flood oxygenation.
Description:
This is a pilot, randomized controlled study that aims to explore the effects of the
combination of two interventions, HRV-BF and nirHEG neurofeedback, on the inhibitory control
of healthy older adults. The study is thus designed with two parallel groups: the
experimental group will receive sessions of HRV-BF and nirHEG NF whereas the control group
will receive sessions in which visual biofeedback will be disabled.
The three tasks used in the present study to appraise inhibitory control are Go/no Go, The
Arrow task and Stroop task whereas impulsive behaviour will be evaluated with the UPPS scale.
In addition, the feeling of self-efficacity and the attitude toward stereotypes will also be
assessed with respectively the Self-efficacity scale and l'Echelle du moral. All these tasks
will be administered at pretest and posttest intervention.
Procedures Healthy older adults will be recruited by public advertisements and flyers posted
at the Universities of Geneva, in sport clubs and various seniors associations.
After a verbal consent and an initial telephone interview (anamnestic questionnaire and
F-TICS-m-Telephone Interview for Cognitive Status questionnaire, Vercambre et al.,2010), the
eligible participants will be asked to attend a first visit during which written informed
consent will be obtained.
After confirmation of eligibility and enrolment, the 50 selected participants will be
randomly assigned to an experimental or a control group each group counting about 25
subjects. First, both study groups will be evaluated with a battery of inhibition and
psychological testing. Then, the experimental group (n=25) will receive 10 biofeedback
training sessions (heart rate variability plus hemoencephalography neurofeedback, 1 hour
session, once a week for 10 weeks. The control group (n=25) will receive sessions in which
visual biofeedback will be disabled.
Both study groups will be evaluated at 2 points - pre and post training on inhibitory
control, impulsivity, heart rate variability levels, hemodynamic response, feeling of
self-efficacity and attitude toward aging.
