Skip to main content
OpenTrials
Completed

NCT Number: NCT04925830

Exploring the Impact of Biofeedback on the Inhibitory Control of Healthy Older Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inhibition Behavior Inhibition, Psychological

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for the Interdisciplinary Study of Gerontology and Vulnerabilities (CIGEV)

Geneva, 1205, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults
  • 65 to 80 years old
  • Native French speakers or speaking French for over 5 years

Exclusion criteria

  • Adults who report <27 on TICS (Telephone Interview for Cognitive Status questionnaire)
  • Adults that report a history of major neurological or psychiatric illness in the present or the past
  • Use of psychotropic drugs

Treatment and study plan

Heart rate variability biofeedback; haemoncephalography biofeedback

Behavioral

Ten 25-minute weekly heart rate variability biofeedback and 30 minute haemoencephalogrphy biofeedback sessions

Primary outcomes

  1. Change in interference score (milliseconds)

    Time frame: Pre-intervention (week 1) - Post-intervention (week 13)

    Between group post-pre interference score change (reaction time) in Arrow task

  2. Change in inhibitory response (milliseconds)

    Time frame: Pre-intervention (week 1) - Post-intervention (week 13)

    Between group post-pre reaction time change in GO no GO

  3. Change in interference score (seconds)

    Time frame: Pre-test (week 1) - Posttest (week 13)

    Between group post-pre interference score in Stroop task

Secondary outcomes

  1. Heart rate variability changes

    Time frame: HRV-baseline (week 2) - HRV-posttest (week 13)

    Between group post-pre change in heart rate variability values (RMSSD, LF, HF)

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Inhibitory Training in Older Adults: a Biofeedback Study

Acronym: I-BF

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2021
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.