Impact of Smoking Cessation on Sleep
戒烟对睡眠的影响
基本信息
- 批准号:7410166
- 负责人:
- 金额:$ 32.24万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2004
- 资助国家:美国
- 起止时间:2004-07-15 至 2010-04-30
- 项目状态:已结题
- 来源:
- 关键词:AbstinenceAdverse effectsAirAmplifiersAntidepressive AgentsArousalArtsAutonomic nervous systemBehaviorBehavioralBrainBreathingBupropionBupropion/NicotineCardiovascular systemCholinergic AgentsConditionCounselingData AnalysesDevelopmentDisruptionDrowsinessEffectivenessElectroencephalographyEquilibriumFailureFemaleHealthHourHumanIndividualInterventionLaboratoriesLeadLiteratureMeasurementMeasuresMedicalMoodsMorbidity - disease rateNatureNicotineNicotine WithdrawalNumbersPatient Self-ReportPerformancePharmacotherapyPlacebosPlayPrevalencePsychological reinforcementRandomizedRelapseRelative (related person)ReportingResearch DesignResearch PersonnelRewardsRoleSamplingSleepSleep DeprivationSleep disturbancesSleeplessnessSmokerSmokingSymptomsSystemTechniquesTestingThinkingTobaccoWithdrawalWithdrawal SymptomWithholding TreatmentWomanbasecholinergiccigarette smokingcostdaydesigndisturbance in affectdysphoriamalemenmortalitynegative moodnicotine patchnicotine replacementprogramspsychologicrespiratorysizesmoking cessationtherapy developmenttreatment effect
项目摘要
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.
说明(申请人提供):绝大多数戒烟尝试都以失败告终,原因有很多,包括出现令人反感的戒烟症状。鉴于持续吸烟的健康后果,治疗无效会导致发病率和死亡率大幅上升,并带来巨大的经济和人力成本。睡眠障碍是常见的症状之一,睡眠障碍本身可以放大许多其他症状,因为在其他医学条件下和实验情况下的睡眠障碍被发现会产生烦躁不安、思考困难和嗜睡。安非他酮是一种有效的戒烟药物,它也有睡眠障碍,这是一种常见的自我报告的副作用,据估计,在戒烟者中的患病率在30%-50%之间。同样,透皮尼古丁的使用与报告的睡眠障碍有关,特别是在使用24小时以上时。安非他酮和尼古丁透皮贴剂的联合治疗在近50%的病例中会产生睡眠障碍,相比之下,使用安慰剂戒烟的吸烟者中这一比例为20%。世界上关于戒烟和客观测量睡眠障碍的S文献基于不到80名受试者。我们建议采用随机四组设计,反复测量戒烟和睡眠障碍,以评估男性和女性吸烟者在行为咨询联合安慰剂安非他酮和尼古丁贴片、活性安非他酮、活性安非他酮和贴片或联合应用安非他酮和尼古丁贴片后戒烟的效果。受试者将接受为期12个月的追踪,以确定是否戒酒(由呼出的空气中的一氧化碳确认)。研究设计的一个关键方面是使用了更新的唤醒定义,这可能更准确地反映戒烟后睡眠中断的真实程度。具体目的是:1)使用最先进的中枢和自主神经系统唤醒测量技术,在超过睡眠实验室研究的吸烟者总数的样本中,表征戒烟对睡眠的影响;2)确定目前推荐的戒烟治疗对睡眠和睡眠干扰的影响;3)评估戒烟治疗对日间困倦和情绪的影响;以及,4)评估嗜睡和情绪障碍对复发的影响。将检验以下假设:1)戒烟将与睡眠障碍、EEG和睡眠中自主神经唤醒的增加相关,并在睡眠期间相对转向交感迷走神经平衡;2)安非他酮和尼古丁透皮贴剂的使用将导致睡眠障碍的进一步增加,超过戒烟后的睡眠障碍;3)与戒烟相关的和与治疗相关的睡眠障碍的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正相关;4)与戒烟相关的睡眠障碍的增加、白天嗜睡和消极情绪将与12个月内的复发正相关;5)药物治疗对戒烟效果的负面影响,女性大于男性。这一项目的结果对于开发有针对性的治疗方法将特别重要,该方法旨在改善睡眠干扰,作为整体戒烟战略的一部分。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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GARY E SWAN其他文献
GARY E SWAN的其他文献
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{{ truncateString('GARY E SWAN', 18)}}的其他基金
SRI International (SRI) Clinical Trial Site and Mechanistic Study
SRI国际(SRI)临床试验场地和机制研究
- 批准号:
8127172 - 财政年份:2010
- 资助金额:
$ 32.24万 - 项目类别:
Biometric and Measured Genetic Research on Smoking
吸烟的生物识别和测量基因研究
- 批准号:
6948914 - 财政年份:2003
- 资助金额:
$ 32.24万 - 项目类别:
Biometric and Measured Genetic Research on Smoking
吸烟的生物识别和测量基因研究
- 批准号:
6792492 - 财政年份:2003
- 资助金额:
$ 32.24万 - 项目类别:
Biometric and Measured Genetic Research on Smoking
吸烟的生物识别和测量基因研究
- 批准号:
7116288 - 财政年份:2003
- 资助金额:
$ 32.24万 - 项目类别:
Biometric and Measured Genetic Research on Smoking
吸烟的生物识别和测量基因研究
- 批准号:
7283520 - 财政年份:2003
- 资助金额:
$ 32.24万 - 项目类别:
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