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Chronic Obstructive Pulmonary Disease (COPD)NCT02991781

Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation

A study testing Biofeedback and Neurofeedback Training and Varenicline use for smoking cessation in people with Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by Aristotle University Of Thessaloniki at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Biofeedback and Neurofeedback Training and Varenicline use for smoking cessation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
3 sitesin 3 countries
Study dates
Jan 2017to Jun 2019
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being continuous tobacco smokers (>10 cigarettes per day) for at least 6 months
  • Being unemployed for at least 3 months
  • Being diagnosed with Asthma
  • Being diagnosed with C.O.P.D.
  • Age < 35, for the group of Young Unemployed
  • Age >35 years, for the groups of Asthma and C.O.P.D. patients

Who cannot join

  • Diagnosed neurological, mental or psychiatric illness
  • Drug-resistance epilepsy

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Bulgaria1 site

  • National Association of General Practitioners in Bulgaria

    Sofia

Other trials in Bulgaria

Cyprus1 site

  • AAI Scientific Cultural Services Ltd (AAISCS)

    Nicosia, 1065

Other trials in Cyprus

Greece1 site

  • Laboratory of Medical Physics, AUTH

    Thessaloniki

Other trials in Greece

About this study

Official title: Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking

This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.

Read the detailed description

This study will develop and experimentally test the efficiency of a neurofeedback(NF) training protocol for smoking cessation. As non-pharmacological, non-invasive and painless brainwave technique, NF contributes to teach individuals how they can take the control of their mind through operant conditioning. NF regulates brain function in natural way. Studies have reported an 80% rate of reducing or eliminating the need for traditional medication14. Therefore, other nicotine substitutes (such as varenicline) which may carry their own toxicity risk factor may become redundant. The protocol will include 5 bio- and 25 Neuro-feedback sessions, lasting approximately 36 months.

The electrophysiological evaluation of the efficacy of the intervention will include EEG resting state and a multifeature Mismatch Negativity (MMN) evoked response measurements before and after the participation of human volunteers. These data will be analyzed in terms of cortical activation patterns and cortical connectivity. Questionnaires will be used to collect behavioral and psychometric data regarding smoking related behaviors. Additionally, a clinical evaluation including spirometry, exhaled carbon monoxide, total antioxidant capacity, vitamine E, and cotinine will be conducted. The data will be collected prior, during, after the completion of the study and after a one-year follow up.

The Neurofeedback intervention will be compared to a different group of participants that will follow an intervention based on varenicline use for approximately 3 months. The electrophysiological evaluation of the efficacy of the intervention will include EEG resting state and a sleep polysomnography measurement. Questionnaires and clinical evaluation include the same measurements as the neurofeedback intervention but only in 3 time points: prior, during, after the completion of the study.

Being tested
Biofeedback and Neurofeedback Training, Varenicline use for smoking cessation, Sham Neurofeedback, Passive Control
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Asthma, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biofeedback and Neurofeedback TrainingOther

    Also called Neurofeedback

    The protocol will consist of 5 sessions of skin temperature biofeedback and 20 sessions of a neurofeedback training protocol that will consist of Alpha-Theta ratio up-training. The aim of the training is to reach a crossover state, were initially Alpha activity will increase and then in a deeper state, the Theta activity will take over. This state is associated with a reverie and disidentification with problems, stress or traumatic experiences. Therefore, the subjects will learn how to increase their Theta/Alpha ratio.

  • Varenicline use for smoking cessationDrug

    Also called Varenicline

    The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.

  • Sham NeurofeedbackOther

    Also called Active Control

    Subjects will receive equal sessions of sham neurofeedback, and thus serve as a control group for the analysis and design of the study.

  • Passive ControlOther

    Subjects will not receive any intervention, but they will be measured via a clinical and psychometric evaluation with a time-difference of 3 months. This is equal to the intervention time. Hence, the subjects in this intervention type will serve as a control group for the analysis and design of the study.

Study groups in NCT02991781
Study groupRoleWhat they receive
COPD PatientsExperimentalC.O.P.D. patients: Presence of a post-bronchodilator forced expiratory volume at one second (FEV1) / forced vital capacity (FVC) < 0.70 with symptoms as dyspnea, chronic cough, chronic sputum production Biofeedback and Neurofeedback Training Varenicline use for smoking cessation Passive Control
Receives: Other: Biofeedback and Neurofeedback Training; Drug: Varenicline use for smoking cessation; Other: Passive Control
Asthma PatientsExperimentalAsthma patients: Presence of 2 or more of symptoms of airflow obstruction (cough, wheezing, dyspnea). Airflow obstruction at least partially reversible demonstrated by spirometry with FEV1 increased by >12% following b2 agonist inhalation) or evidence of bronchial hyperresponsiveness by metacholine provocation test (demonstrated by provocative concentration causing a 20% fall (PC20) <8 mg or mannitol provocation test (with FEV1 decrease of 15%) Biofeedback and Neurofeedback Training Varenicline use for smoking cessation Passive Control
Receives: Other: Biofeedback and Neurofeedback Training; Drug: Varenicline use for smoking cessation; Other: Passive Control
SmokersExperimentalSmokers will consist of a group of patients that are under the age of 35, unemployed and healthy according to a standard clinical evaluation. Biofeedback and Neurofeedback Training Varenicline use for smoking cessation Sham Neurofeedback Passive Control
Receives: Other: Biofeedback and Neurofeedback Training; Drug: Varenicline use for smoking cessation; Other: Sham Neurofeedback; Other: Passive Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurofeedback vs. Varenicline efficacy for smoking cessation

    The outcome measure is the effect size of each intervention measured in standardized percentage of participants that give up smoking.

    Measured: 2 years

Secondary outcomes (7)

  1. Effectiveness in changing quality of life as measured by EuroQL-5D

    The outcome measure is the change from baseline in the scoring of the a questionnaire evaluating quality of life (EuroQL-5D), after the completion of the intervention.

    Measured: 2 years

  2. General health

    The outcome measure is the change from baseline in the scoring of the General Health Questionnaire which is evaluating general health, after the completion of the intervention.

    Measured: 2 years

  3. Depression

    The outcome measure is the change from baseline in the scoring of the Beck's Depression Inventory, which is evaluating depression, after the completion of the intervention.

    Measured: 2 years

  4. Anxiety

    The outcome measure is the change from baseline in the scoring of the Spielberger's State -Trait Anxiety Inventory , which is evaluating anxiety, after the completion of the intervention.

    Measured: 2 years

  5. Neuroplastic effects of combined bio- and neuro- feedback training in the resting state cortical activity

    The outcome measure is the change from baseline in the activation of the resting state cortical network after the completion of the intervention.

    Measured: 2 years

  6. Neuroplastic effects of combined bio- and neuro- feedback training in the mismatch negativity response

    The outcome measure is the change from baseline in the activation of the Mismatch Negativity response of the auditory cortex after the completion of the intervention.

    Measured: 2 years

  7. Sleep quality during varenicline use

    The outcome measure is the change from baseline in the scoring in psychometric tests evaluating sleep quality.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJun 2019
  4. Study completionJun 2019

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02991781
Sponsor's protocol ID
SEP-210254111
Status last verified
Feb 2020
First submitted
5 May 2015
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Individual Patient Data (IPD) will be shared after obtaining the consent of the participants. The consent form will inform the participants for this attribute of the data. The repository will be based on popular open source software (CKAN) and it'll be accessible through a portal (endpoint) at the following address: ckan.smokefreebrain.eu CKAN is a powerful data management system that makes data accessible - by providing tools to streamline publishing, sharing, finding and using data. CKAN is aimed at data publishers (national and regional governments, companies and organizations) wanting to make their data open and available.

Publications

  • Bamidis PD, Paraskevopoulos E, Konstantinidis E, Spachos D, Billis A. Multimodal e-Health Services for Smoking Cessation and Public Health: The SmokeFreeBrain Project Approach. Stud Health Technol Inform. 2017;245:5-9.

    PubMed 29295041

  • Pandria N, Athanasiou A, Styliadis C, Terzopoulos N, Mitsopoulos K, Paraskevopoulos E, Karagianni M, Pataka A, Kourtidou-Papadeli C, Makedou K, Iliadis S, Lymperaki E, Nimatoudis I, Argyropoulou-Pataka P, Bamidis PD. Does combined training of biofeedback and neurofeedback affect smoking status, behavior, and longitudinal brain plasticity? Front Behav Neurosci. 2023 Jan 27;17:1096122. doi: 10.3389/fnbeh.2023.1096122. eCollection 2023.

    PubMed 36778131

Questions about this trial

What is this clinical trial studying?

A study testing Biofeedback and Neurofeedback Training and Varenicline use for smoking cessation in people with Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by Aristotle University Of Thessaloniki at 3 sites in 3 countries.

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 6 inclusion and 2 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Bulgaria, Cyprus, Greece. 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?

Neurofeedback vs. Varenicline efficacy for smoking cessation (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02991781, which also lists 2 linked publications.

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 17 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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