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

NCT04925830 | Completed

• 1 other identifier: 34_DT_Biofeedback
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inhibition

Outcome Measures

Primary Outcomes (3)

• Change in interference score (milliseconds)

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

  Pre-intervention (week 1) - Post-intervention (week 13)

• Change in inhibitory response (milliseconds)

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

  Pre-intervention (week 1) - Post-intervention (week 13)

• Change in interference score (seconds)

  Between group post-pre interference score in Stroop task

  Pre-test (week 1) - Posttest (week 13)

Secondary Outcomes (1)

• Heart rate variability changes

  HRV-baseline (week 2) - HRV-posttest (week 13)

Study Arms (2)

BF Group

EXPERIMENTAL

Participants of the BF group are connected with a plethysmograph and a respiration belt in order to assess HRV indices. HRV-BF is principally given by means of a vertical bar graph dynamically varying in height and two graphic curves referring to the heart rate (in beats per minute) and physiological breathing pattern, (inspiration and expiration). Each nirHEG- BF session occurs after a ten-minute pause from the end of the HRV-BF training. nirHEG-BF is principally given by means of a vertical bar graph dynamically varying in height and represented on a computer monitor. The height of the change according to the hemodynamic response measured at each of the three prefrontal points (Fp1, Fpz, Fp2) To maintain motivation, the bar graph is associated with a game-like animation (puzzle) signaling successful regulation, e.g. by forwarding motion of the pieces of a puzzle.

Behavioral: Heart rate variability biofeedback; haemoncephalography biofeedback

No BF Group

NO INTERVENTION

The no BF group receive the same sensors and is exposed to the same environment of the BF group but real time biofeedback of physiological parameters (HRV and hemodynamic response) is deactivated so that participants can watch documentary videos without interruption.

Interventions

Heart rate variability biofeedback; haemoncephalography biofeedback BEHAVIORAL

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

BF Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

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

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Inhibition, Psychological

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Matthias Kliegel, Professor

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 14, 2021
• Study Start: August 18, 2020
• Primary Completion: June 17, 2021
• Study Completion: June 17, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)