Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Neurofeedback vs. Varenicline efficacy for smoking cessation
研究概览
简要总结
This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Diagnosed neurological, mental or psychiatric illness
- •Drug-resistance epilepsy
研究组 & 干预措施
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
干预措施: Biofeedback and Neurofeedback Training (Other)
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
干预措施: Varenicline use for smoking cessation (Drug)
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
干预措施: Passive Control (Other)
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
干预措施: Biofeedback and Neurofeedback Training (Other)
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
干预措施: Varenicline use for smoking cessation (Drug)
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
干预措施: Passive Control (Other)
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
干预措施: Biofeedback and Neurofeedback Training (Other)
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
干预措施: Varenicline use for smoking cessation (Drug)
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
干预措施: Sham Neurofeedback (Other)
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
干预措施: Passive Control (Other)
结局指标
主要结局
Neurofeedback vs. Varenicline efficacy for smoking cessation
时间窗: 2 years
The outcome measure is the effect size of each intervention measured in standardized percentage of participants that give up smoking.
次要结局
- 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)
研究者
Panos Bamidis
Dr. Panagiotis Bamidis
Aristotle University Of Thessaloniki