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临床试验/NCT04265339
NCT04265339Unknown不适用

The Interplay Between Addiction to Tobacco Smoking and Sleep Quality Among Healthy Adults

The Max Stern Academic College Of Emek Yezreel2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Change from Baseline State Anxiety at 6 months

研究概览

简要总结

Tobacco smoking is a major health problem, leading to considerable morbidity and mortality due to cancer, impaired pulmonary function, and cardiovascular diseases. Chronic nicotine consumption related to smoking may affect pulmonary function and can cause neuronal alterations leading to increased emotional distress and decreased cognitive functioning, especially when the smoker attempts to quit. These may explain the huge difficulty in quitting and the dependence on cigarettes as a means of maintaining emotional balance. The possibility that reduced sleep quality is a major negative outcome that contributes to nicotine addiction has been largely overlooked. Several studies have shown that smoking and smoking cessation disrupt sleep quality; however, the vast majority of these studies were based on subjective reports. Moreover, it is not clear to what degree disrupted sleep quality among smokers may be related to reduced pulmonary function, and to what degree reduced sleep quality contributes to the emotional cognitive distress of active and abstinent smokers and to their urge to smoke. The main hypothesis of this proposal is that smoking and early phases of smoking cessation will be associated with reduced sleep quality. This poor sleep quality will be associated with emotional and cognitive symptoms and difficulty in abstaining from tobacco smoking. Successful abstinence from smoking over time will lead to normalization of the quality of sleep.

Experiments to investigate this hypothesis will be conducted on healthy young adults addressing the following specific aims: 1) To examine physiological and psychological factors predicting reduced quality of sleep among smokers, including: poor pulmonary function, the degree of nicotine dependence, altered regulation of stress systems (HPA axis and the sympathetic nervous system), and emotional distress (anxiety and depression); 2) To explore the impact of smoking cessation on sleep quality and related symptoms. Specifically, whether smoking cessation induces fragmented sleep and poor sleep quality, and whether the diminished sleep quality can predict the magnitude of emotional and cognitive symptoms; 3) To examine whether poor sleep (before and during abstinence) can predict the level of the urge to smoke and smoking relapse among abstinent smokers; 4) To explore whether sleep quality ultimately improves following prolonged abstinence from smoking. Addressing these aims, nonsmokers and smokers will be examined before and during smoking abstinence on the following measures: quality of sleep via actigraphy and polysomnography (PSG), pulmonary function test, biological markers of stress (cortisol and α-amylase) and smoking (i.e., cotinine, the main metabolite of nicotine), and emotional and cognitive functioning via psychometric tests.

Results of this study will provide novel insight on the role of sleep in nicotine addiction. Experiments will show how reduced quality of sleep may result from chronic smoking and interfere with attempts to quit smoking. Also, the experiment will shed light on the interrelated physiological and psychological mechanisms that mediate the interplay between smoking addiction and sleep. The research will utilize a variety of powerful methods and an interdisciplinary collaboration of experts in the fields of sleep, addiction, and pulmonary medicine. It is anticipated that the results will contribute substantially to our knowledge of smoking addiction and may promote the development of effective therapeutic interventions to this major public health problem.

详细描述

Scientific background Tobacco smoking is a major health problem, leading to considerable morbidity and mortality due to cancer, pulmonary illnesses, and cardiovascular diseases (Taghizadeh, Vonk & Boezen, 2016). The main psychoactive and addictive substance in tobacco is nicotine (Zaparoli & Galduroz, 2012). Nicotine addiction is a complex phenomenon that involves both physical and psychological dependence (Cohrs et al., 2014), which causes not only difficulty in quitting but also a strong tendency to return to smoking after having quit for a long time) Zaniewska, Przegalinski & Fillip, 2009).

A common theoretical model of addiction (Koob & Volkow, 2016) holds that the transition from occasional smoking to addiction involves an upregulation of neurobiological stress systems. Consequently, even a brief period of abstinence from smoking, leading to reduced concentration of nicotine in the body, induces both emotional withdrawal symptoms (anxiety, restlessness, irritability, anhedonia) and cognitive withdrawal symptoms (diminished memory and attention) that may in turn produce a compulsive urge to smoke again, in order to ease the unpleasant sensations (Koob & Volkow, 2016). Although some studies suggest reduced quality of sleep is also among the consequences of smoking and smoking cessation (Cohrs et al., 2014; Colrain, Trinder & Swan, 2004) this issue was not fully explored, and the contribution of the reduced quality of sleep to negative emotional situations and to the motivation to smoke is unclear.

Smoking and sleep. Smokers report more sleep disturbances such as insomnia (i.e., a variety of complaints reflecting dissatisfaction with the ability to initiate and maintain sleep, along with a significant reduction in total sleep time followed by daytime sleepiness) (Kaneita et al., 2005; Phillips & Danner, 1995), and a correlation was found between the level of addiction to cigarettes and reduced quality of sleep (Palmer, Harrison & Hiorns, 1980; Patten et al., 2000). A deleterious effect of smoking on the quality of sleep could partially result from disturbed pulmonary function (Simon-Tuval et al., 2011). Indeed, heavy smokers are at high risk for Chronic Obstructive Pulmonary Disease (COPD) (Tarasiuk et al., 2006), which causes disturbed sleep leading to reduced quality of life (Scharf et al., 2011; Won & Kryger, 2014). Moreover, even in young, seemingly healthy, moderate smokers there is a clear reduction in pulmonary function, and a negative correlation was found in healthy adults between pulmonary functioning and sleep quality (Phillips et al., 1989). However, this factor could not solely explain the relationship between smoking and quality of sleep, as studies have shown an increased number of awakenings in the course of the night during early phases of smoking cessation (Hatsukami, Hughes & Pickens, 1985; Hatsukami et al., 1988).

The reliability of subjective sleep measures is not unequivocal and needs support from objective measurements (Pillar, Malhotra & Lavie, 2000). To date, only a handful of studies compared the sleep architecture of active and quitting smokers to that of nonsmokers using polysomnographic (PSG) tests (consisting of brain wave, muscle tension, eye movement, and other measurements). These studies confirmed the deleterious effects of smoking and smoking cessation on the quality of sleep. Zhang and colleagues (2006) found that compared to nonsmokers, the sleep of smokers was characterized by shorter duration, longer time to reach (rapid eye movement) REM sleep, longer time spent in light sleep (stage 1), less time spent in deep sleep (stages 3 and 4, slow-wave sleep-SWS), and lower sleep efficiency (percentage of actual sleep time of the total time spent in bed). Similarly, sleep duration among smokers was shorter than among nonsmokers (Jaehne et al., 2012). Likewise, PSG tests conducted on individuals undertaking smoking cessation demonstrated increases in the number of awakenings at night (Prosise et al., 1994), shortening of REM latency, shortening of SWS sleep duration, and extension of the phases of light sleep (stages 1 and 2) (Moreno-Coutiño, Calderón-Ezquerro & Drucker-Colín, 2007; Wetter et al., 2000), all indications of reduced quality of sleep. Yet, these PSG studies also had limitations as they were usually conducted on a small number of patients on a single night, under the artificial conditions of sleep laboratories.

Quality of sleep, stress, and addiction to smoking. It is well accepted that sleep plays a vital role in health as well as behavioral and emotional stability (Scharf et al., 2010; Tarasiuk et al., 2005). Those who suffer from poor sleep quality exhibit higher rates of psychological stress, depression, and various anxiety symptoms than the general population (Fernández-Mendoza et al., 2009; Ohayon, 2005). The tendency toward poor sleep quality among smokers and quitters, and the correlation between proper sleep and behavioral and emotional stability raise the hypothesis that the impairment in sleep quality among smokers and quitters affects their psychological functioning and their smoking behavior. The few studies that investigated this issue demonstrated that abstaining from cigarette smoking for 48 hours increased the subsequent rate of smoking (Hamidovic& de Wit, 2009), and that sleep disruptions during withdrawal have a negative effect on the success of smoking cessation (Jaehne et al., 2009; Persico, 1992). These findings seem to integrate well into the aforementioned theoretical model, which holds that exposure to nicotine leads to the development of aversive psychological symptoms when the bodily nicotine concentration drops, which leads to a compulsive urge to smoke to alleviate these unpleasant sensations (Cohen & George, 2013).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

The data analysis will be conducted without knowledge of the group assignment

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • For the smokers group:
  • At least 10 cigarettes a day on average, for the preceding 2 years
  • Meeting the criteria for tobacco use disorder laid out in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  • For the nonsmokers group:
  • Not having smoked more than 5 cigarettes in their lifetime and not at all in the preceding 2 years.

排除标准

  • History of mental illness or substance abuse.
  • Working on night shifts.
  • Pregnancy
  • Clinical diagnosis of a sever lung disease, such as Chronic Obstructive Pulmonary Disease (COPD)
  • Clinical diagnosis of a severe sleeping disorder, such as sleep apnea, narcolepsy and hypersomnia

结局指标

主要结局

Change from Baseline State Anxiety at 6 months

时间窗: Once at baseline, Once at the end of the first week of smoking cessation, Once 3 month after smoking cessation and Once 6 month after smoking cessation

State-Trait Anxiety Inventory (STAI).The portion of the questionnaire that assesses state anxiety includes 20 items, each a statement relating to the participant's sense of anxiety at that point in time. Participants indicate agreement with each statement on a 4-point scale (1-4). The scores are added for a final score (20-80), with a higher score indicating a more severe state of anxiety.

Change from Baseline Pulmonary Function as measured by spirometry (the volume and speed of air that can be inhaled and exhaled) at 6 months

时间窗: Once at baseline, Once at the end of the first week of smoking cessation, Once 3 month after smoking cessation and Once 6 month after smoking cessation

The parameters measured in spirometry are Vital Capacity (VC), Forced Vital Capacity (FVC), Forced Expiratory Volume (FEV), Forced Expiratory Flow (FEF), and Maximal Voluntary Ventilation (MVV).

Change from Baseline Objective Sleep Quality at 6 months

时间窗: Two weeks at baseline, During first week of smoking cessation, for two weeks 3 month after smoking cessation and for two weeks 6 month after smoking cessation

Actigraphy

Change from Baseline Sleep Structure at 6 months

时间窗: Two nights at baseline, one night at the end of the first week of smoking cessation, one night 3 month after smoking cessation and one night 6 month after smoking cessation

Polysomnography (PSG)

Change from Baseline Depressive Symptoms at 6 months

时间窗: Once at baseline, Once at the end of the first week of smoking cessation, Once 3 month after smoking cessation and Once 6 month after smoking cessation

Beck's Depression Inventory (BDI-II). Includes 21 items, each consisting of four statements representing increasing levels of severity of a particular depressive symptom. Participants specify which statement best describes their feeling in the preceding week. The scores are added for a final score (0-63), . with a higher score indicating a more severe state of depression.

Change from Baseline Exhaled Carbon Monoxide at 6 months

时间窗: Once at baseline, 4 times during the first week of smoking cessation (day 2, day 3, day 5, day 7), Once 3 month after smoking cessation and Once 6 month after smoking cessation

Carbon monoxide (CO) exhalation level

Change from Baseline Biological Markers of Stress and Tobacco Smoking at 6 months

时间窗: Once at baseline, Once at the end of the first week of smoking cessation, Once 3 month after smoking cessation and Once 6 month after smoking cessation

Salivary levels of cortisol, α-amylase, and cotinine

Change from Baseline Subjective Sleep Quality at 6 months

时间窗: Once at baseline, Once at the end of the first week of smoking cessation,Once 3 month after smoking cessation and Once 6 month after smoking cessation

The Pittsburgh Sleep Quality Index (PSQI).The questionnaire consists of 19 individual items, generating seven "component" scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores are added to yield one "global" score, with a range of 0-21 points, with higher scores indicating more severe sleep difficulties.

Change from Baseline Tobacco Smoking urge at 6 months

时间窗: Once at baseline, Once at the end of the first week of smoking cessation,Once 3 month after smoking cessation and Once 6 month after smoking cessation

Brief Questionnaire on Smoking Urges (QSU). consists of 10 items, each a statement referring to the amount of craving for a cigarette at a given point in time. Participants indicate the level of their agreement with each statement on a 7-point Likert scale (1-7). The final score is the sum of all responses (range:10-70), with a higher score indicating a stronger urge to smoke.

Change from Baseline Cognitive Functioning at 6 months

时间窗: Once at baseline, Once at the end of the first week of smoking cessation,Once 3 month after smoking cessation and Once 6 month after smoking cessation

Cognitive Assessment Battery (CAB)

Change from Baseline Tobacco Smoking Dependence at 6 months

时间窗: Once at baseline, Once at the end of the first week of smoking cessation,Once 3 month after smoking cessation and Once 6 month after smoking cessation

Minnesota Nicotine Withdrawal Scale (MNWS).The questionnaire includes nine items, each describing a specific nicotine withdrawal symptom. Participants indicate the degree of severity with which they experienced each symptom in the preceding 24 hours on a 5-point scale (0-4). The items are averaged for a single severity score (0-4), with a higher score indicating a more severe level of dependence.

次要结局

未报告次要终点

研究者

发起方
The Max Stern Academic College Of Emek Yezreel
申办方类型
Other
责任方
Sponsor

研究点 (2)

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