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

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ClinicalTrials.gov Identifier: NCT04265339
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
The Max Stern Academic College Of Emek Yezreel

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tobacco Dependence Other: Smoking cessation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three study groups: Smokers, non-smokers and smoking cessation group.
Masking: Single (Outcomes Assessor)
Masking Description: The data analysis will be conducted without knowledge of the group assignment
Primary Purpose: Basic Science
Official Title: The Interplay Between Addiction to Tobacco Smoking and Sleep Quality Among Healthy Adults
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : October 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: None smokers
50 participants who are non-smokers
Experimental: Smoking Cessation
50 smokers who quit smoking
Other: Smoking cessation
Participants are required to quit smoking

No Intervention: Active smokers
50 smokers who continue smoking



Primary Outcome Measures :
  1. Change from Baseline Objective Sleep Quality at 6 months [ Time Frame: 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

  2. Change from Baseline Sleep Structure at 6 months [ Time Frame: 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)

  3. Change from Baseline Subjective Sleep Quality at 6 months [ Time Frame: 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.

  4. Change from Baseline Tobacco Smoking Dependence at 6 months [ Time Frame: 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.

  5. Change from Baseline Tobacco Smoking urge at 6 months [ Time Frame: 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.

  6. Change from Baseline Depressive Symptoms at 6 months [ Time Frame: 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.

  7. Change from Baseline State Anxiety at 6 months [ Time Frame: 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.

  8. Change from Baseline Biological Markers of Stress and Tobacco Smoking at 6 months [ Time Frame: 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

  9. Change from Baseline Exhaled Carbon Monoxide at 6 months [ Time Frame: 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

  10. Change from Baseline Cognitive Functioning at 6 months [ Time Frame: 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)

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



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265339


Contacts
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Contact: Ami Cohen, phD 97246423541 ext 97246423541 desiv@yvc.ac.il
Contact: Iris Haimov, Professor 9724642765 i_haimov@yvc.ac.il

Locations
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Israel
The Max Stern Academic College of Emek Yezreel Recruiting
Afula, Israel, 19300
Contact: Iris Haimov, Ph.D.    0097246423612    i_haimov@yvc.ac.il   
Principal Investigator: Iris Haimov, Ph.D.         
Sponsors and Collaborators
The Max Stern Academic College Of Emek Yezreel
Publications:
Granger DA. Children's salivary cortisol, internalising behavior problems, and family environment: Results from the Concordia Longitudinal Risk Project. International Journal Of Behavioral Development 22(4): 707-728, 1998.
Sadeh A, Alster J, Urbach D, Lavie, P. Actigraphically based automatic bedtime sleep-wake scoring: Validity and clinical applications. Journal of Ambulatory Monitoring 2(3): 209-216, 1989.

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Responsible Party: The Max Stern Academic College Of Emek Yezreel
ClinicalTrials.gov Identifier: NCT04265339    
Other Study ID Numbers: 1497/17
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Max Stern Academic College Of Emek Yezreel:
Sleep
Tobacco Smoking
Smoking cessation
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders