Impact of Smoking Cessation on Sleep

戒烟对睡眠的影响

• 批准号: 6732457
• 负责人: GARY E SWAN
• 金额: $ 38.91万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-15 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6732457
• 关键词: antidepressants; arousal; behavioral /social science research tag; bupropion; clinical research; combination therapy; counseling; drug /alcohol abstinence; drug abuse chemotherapy; drug adverse effect; drug withdrawal; electroencephalography; emotions; gender difference; health services research tag; human subject; nicotine replacement; patient oriented research; performance; polysomnography; relapse /recurrence; sleep; sleep disorders; smoking cessation; therapy adverse effect; wakefulness

DESCRIPTION (provided by applicant): The vast majority of attempts to quit smoking end in failure due to many reasons including the presence of aversive withdrawal symptoms. Given the health consequences of continued smoking, treatment ineffectiveness leads to substantially elevated morbidity and mortality, with immense financial and human cost. One of the commonly reported symptoms, sleep disturbance by itself, can act as an amplifier of many of the other symptoms, as sleep disturbance in other medical conditions and in experimental situations has been found to produce dysphoria, difficulty thinking, and drowsiness. Bupropion, an agent effective in assisting smoking cessation, also has sleep disturbance as a commonly identified self-reported side effect with prevalence estimates of from 30-50 percent among quitting smokers. Likewise, the use of transdermal nicotine is associated with reported sleep disturbance, especially when used over 24 hours. Combination treatment of bupropion and transdermal nicotine has been shown to produce sleep disturbance in nearly 50 percent of cases, compared to 20 percent of quitting smokers using a placebo. The world' s literature on smoking cessation and objectively measured sleep disturbance is based on fewer than 80 subjects. We propose to utilize a randomized, four-group design with repeated measurements of withdrawal and sleep disturbance to evaluate the effect of smoking cessation following treatment with behavioral counseling in combination with either placebo bupropion and nicotine patch, active bupropion, active patch, or combined active bupropion and patch in male and female smokers. Subjects will be followed for a period of twelve months to determine abstinence (confirmed by expired-air CO). A key aspect of the research design is the use of newer definitions of arousal that may more accurately reflect the true extent of sleep disruption following smoking cessation. The specific aims are to: 1) characterize the effect of smoking cessation on sleep using state-of-the-art techniques in measurement of central and autonomic nervous system arousal, in a sample larger than the total number of smokers studied in sleep laboratories to date; 2) determine the impact of currently recommended smoking cessation treatments on sleep and sleep disturbance; 3) evaluate the impact of smoking cessation treatments on daytime sleepiness and mood; and, 4) assess the effect of sleepiness and mood disturbance on relapse. The following hypotheses will be tested: 1) Smoking cessation will be associated with disturbed sleep, increases in EEG and autonomic arousals from sleep, and a relative shift to sympathetico-vagal balance during the sleep period; 2) The use of bupropion and transdermal nicotine will lead to further increases in sleep disturbance over and above those seen with smoking cessation; 3) The cessation-related and treatment-related increases in sleep disturbance will be positively related to an increase in daytime sleepiness and negative mood, and decreased daytime performance; 4) The cessation-related increase in sleep disturbance, daytime sleepiness, and negative mood will positively correlate with relapse within twelve months; 5) The negative impacts of pharmacotherapy treatment for the withdrawal effects of smoking cessation will be greater in women than in men. The results of this project will be particularly important for the development of targeted treatment approaches designed to ameliorate sleep disruption as part of an overall smoking cessation strategy.

描述（由申请人提供）：绝大多数戒烟尝试由于许多原因而失败，包括令人厌恶的戒断症状的存在。考虑到持续吸烟的健康后果，治疗无效导致发病率和死亡率大幅上升，并造成巨大的财政和人力成本。其中一个常见的症状，睡眠障碍本身，可以作为许多其他症状的放大器，因为在其他医疗条件和实验情况下的睡眠障碍已被发现会产生烦躁不安，思维困难和嗜睡。安非他酮是一种有效帮助戒烟的药物，也有睡眠障碍，这是一种常见的自我报告的副作用，在戒烟者中的患病率估计为30- 50%。同样，经皮尼古丁的使用与报告的睡眠障碍有关，特别是当使用超过24小时时。安非他酮和透皮尼古丁的联合治疗已被证明在近50%的病例中产生睡眠障碍，而使用安慰剂的戒烟者只有20%。世界上关于戒烟和客观测量睡眠障碍的文献是基于不到80名受试者。我们建议采用随机、四组设计，重复测量戒断和睡眠障碍，以评估男性和女性吸烟者接受行为咨询联合安慰剂安非他酮和尼古丁贴剂、活性安非他酮、活性贴剂或活性安非他酮和贴剂联合治疗后戒烟的效果。将对受试者进行为期12个月的随访，以确定禁欲情况（通过呼吸空气CO确认）。研究设计的一个关键方面是使用更新的唤醒定义，这可能更准确地反映戒烟后睡眠中断的真实程度。具体目标是：1）使用最先进的中枢和自主神经系统唤醒测量技术，在样本中描述戒烟对睡眠的影响，该样本大于迄今为止在睡眠实验室研究的吸烟者总数; 2）确定目前推荐的戒烟治疗对睡眠和睡眠障碍的影响; 3）评估戒烟治疗对白天嗜睡和情绪的影响;评估嗜睡和情绪障碍对复发的影响。将检验以下假设：1）戒烟将与睡眠紊乱、睡眠中EEG和自主觉醒增加以及睡眠期间交感神经-迷走神经平衡的相对转移相关; 2）使用安非他酮和经皮尼古丁将导致睡眠紊乱进一步增加，超过戒烟时观察到的情况; 3）停药相关和治疗相关的睡眠障碍增加将与白天嗜睡和消极情绪的增加以及白天表现的下降呈正相关;（4）戒断相关的睡眠障碍、白天嗜睡和消极情绪的增加与12个月内的复发呈正相关; 5）药物治疗对戒烟戒断效应的负面影响在女性中比男性更大。该项目的结果对于开发旨在改善睡眠中断的靶向治疗方法特别重要，作为整体戒烟策略的一部分。