Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking
Overview
- Phase
- Not Applicable
- Intervention
- Biofeedback and Neurofeedback Training
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Aristotle University Of Thessaloniki
- Enrollment
- 106
- Locations
- 3
- Primary Endpoint
- Neurofeedback vs. Varenicline efficacy for smoking cessation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.
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.
Investigators
Panos Bamidis
Dr. Panagiotis Bamidis
Aristotle University Of Thessaloniki
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Diagnosed neurological, mental or psychiatric illness
- •Drug-resistance epilepsy
Arms & Interventions
COPD Patients
C.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
Intervention: Biofeedback and Neurofeedback Training
COPD Patients
C.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
Intervention: Varenicline use for smoking cessation
COPD Patients
C.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
Intervention: Passive Control
Asthma Patients
Asthma 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
Intervention: Biofeedback and Neurofeedback Training
Asthma Patients
Asthma 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
Intervention: Varenicline use for smoking cessation
Asthma Patients
Asthma 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
Intervention: Passive Control
Smokers
Smokers 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
Intervention: Biofeedback and Neurofeedback Training
Smokers
Smokers 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
Intervention: Varenicline use for smoking cessation
Smokers
Smokers 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
Intervention: Sham Neurofeedback
Smokers
Smokers 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
Intervention: Passive Control
Outcomes
Primary Outcomes
Neurofeedback vs. Varenicline efficacy for smoking cessation
Time Frame: 2 years
The outcome measure is the effect size of each intervention measured in standardized percentage of participants that give up smoking.
Secondary Outcomes
- Depression(2 years)
- Anxiety(2 years)
- General health(2 years)
- Neuroplastic effects of combined bio- and neuro- feedback training in the mismatch negativity response(2 years)
- Effectiveness in changing quality of life as measured by EuroQL-5D(2 years)
- Neuroplastic effects of combined bio- and neuro- feedback training in the resting state cortical activity(2 years)
- Sleep quality during varenicline use(2 years)