InhibitionI-BFNCT04925830
Exploring the Impact of Biofeedback on the Inhibitory Control of Healthy Older Adults
A study testing Heart rate variability biofeedback; haemoncephalography biofeedback in people with Inhibition, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inhibition
- What is being tested?
- Heart rate variability biofeedback; haemoncephalography biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Aug 2020to 17 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy adults
- 65 to 80 years old
- Native French speakers or speaking French for over 5 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for the Interdisciplinary Study of Gerontology and Vulnerabilities (CIGEV)
Geneva, 1205
About this study
Official title: Inhibitory Training in Older Adults: a Biofeedback Study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Inhibition
- Being tested
- Heart rate variability biofeedback; haemoncephalography biofeedback
- Medical subject headings
- Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedback; haemoncephalography biofeedbackBehavioural
Ten 25-minute weekly heart rate variability biofeedback and 30 minute haemoencephalogrphy biofeedback sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in interference score (milliseconds)
Between group post-pre interference score change (reaction time) in Arrow task
Measured: Pre-intervention (week 1) - Post-intervention (week 13)
Change in inhibitory response (milliseconds)
Between group post-pre reaction time change in GO no GO
Measured: Pre-intervention (week 1) - Post-intervention (week 13)
Change in interference score (seconds)
Between group post-pre interference score in Stroop task
Measured: Pre-test (week 1) - Posttest (week 13)
Secondary outcomes (1)
Heart rate variability changes
Between group post-pre change in heart rate variability values (RMSSD, LF, HF)
Measured: HRV-baseline (week 2) - HRV-posttest (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start18 Aug 2020
- Primary completion17 Jun 2021
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InhibitionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Kliegel, University Hospital, Geneva
- Investigators
- Matthias Kliegel, Professor, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925830
- Sponsor's protocol ID
- 34_DT_Biofeedback
- Acronym
- I-BF
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibitory Training in Older Adults: a Biofeedback Study
- ClinicalTrials.gov ID
- NCT04925830
- Acronym / sponsor ID
- I-BF / 34_DT_Biofeedback
- Conditions
- Inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF Group | Experimental | Behavioral: Heart rate variability biofeedback; haemoncephalography biofeedbackParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Healthy adults
- 65 to 80 years old
- Native French speakers or speaking French for over 5 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability biofeedback; haemoncephalography biofeedbackTen 25-minute weekly heart rate variability biofeedback and 30 minute haemoencephalogrphy biofeedback sessions | Behavioural | BF Group |
Primary outcome
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
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
Change in interference score (seconds)
Time frame: Pre-test (week 1) - Posttest (week 13)
Between group post-pre interference score in Stroop task
1 secondary outcome
Heart rate variability changes
Time frame: HRV-baseline (week 2) - HRV-posttest (week 13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Kliegel, Professor principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability biofeedback; haemoncephalography biofeedback in people with Inhibition, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in interference score (milliseconds) (time frame: Pre-intervention (week 1) - Post-intervention (week 13)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.