The Effect of Cigarette Smoke on Sleep Quality and Physical Activity in People With Multiple Sclerosis

NCT05046535 | Completed

• 1 other identifier: 2021-2020/26
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Current evidence suggests that cigarette smoke increases disease progression in people with multiple sclerosis (PwMS) and worsen their symptoms. 70% of PwMS report sleep disturbances that negatively affects their quality of life. Cigarette smoke has been found to be associated with sleep disturbances in healthy adult smokers, but this relationship is unknown in PwMS. Also, those who smoke cigarettes have less physical endurance resulting in undesirable effects on physical activity. Also, current evidence suggests that genes play a major role in smoking behavior and that certain genetic differences greatly affects nicotine dependence. To our knowledge, this was never explored before among PwMS. This study aims to explore the association between cigarette smoke, sleep quality, and physical activity in PwMS. Another aim is to explore the genetic susceptibility of people with MS to cigarette smoke, specifically to nicotine dependence

Conditions

Multiple Sclerosis

Keywords

Sleep quality; Cigarette Smoking; Physical Activity; Secondhand smoke

Outcome Measures

Primary Outcomes (3)

• Nicotine and cotinine serum levels

  Cotinine serum level which is a major metabolite of nicotine and the preferred biomarker for measuring tobacco use will be measured together with nicotine levels using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Analysis of serum cotinine and nicotine levels will be performed in collaboration with Smart Labs group which is a certified external medical laboratory and the only facility in Jordan that analyze serum nicotine levels. Blood samples will be collected and stored at the CTC then transferred to Smart Labs for analyses.

  6 months

• Sleep quality

  Sleep quality will be assessed subjectively using the following surveys which are validated in PwMS and are available in Arabic language: Pittsburgh Sleep Quality Index that assess global sleep quality, Epworth Sleepiness Scale that assess daytime sleepiness, Insomnia Severity Index that assess the risk of having insomnia, and STOP-Bang questionnaire that assesses the risk of having obstructive sleep apnea.

  6 months

• Physical activity and cardiorespiratory fitness

  Physical activity will be assessed subjectively using the International Physical Activity Questionnaire, and objectively using the 6-Minute Walk Test which is a measure of physical performance and endurance. Maximum Volume of Oxygen consumption (VO2 Max) which is a measure of cardiorespiratory fitness will be quantified using the submaximal test on the recumbent stepper machine.

  6 months

Secondary Outcomes (1)

• Genetic predisposition to nicotine dependence and other blood tests

  6 months

Other Outcomes (4)

• Depression

  6 months

• Fatigue

  6 months

• Manual dexterity

  6 months

Study Arms (2)

Smokers

Individuals with MS who are current tobacco smokers: Either cigarettes, hookah pipe, E-cigarettes or other forms of tobacco. This group will perform all the assessments including surveys about nicotine dependence and smoking behavior.

Behavioral: Sleep quality and physical activity; Genetic: Nicotine dependence; Diagnostic Test: Nicotine and cotinine serum levels; Behavioral: Smoking

Non-smokers

Individuals with MS who are non-smokers of any form of tobacco. This group will perform all the assessments except for the surveys related to nicotine dependence and smoking behavior.

Behavioral: Sleep quality and physical activity; Diagnostic Test: Nicotine and cotinine serum levels

Interventions

Sleep quality and physical activity BEHAVIORAL

Self-reported assessments will be used to measure the following: overall sleep quality, insomnia symptoms, Obstructive sleep apnea. Physical activity will be measured objectively using the 6MWT, 9HPT, and cardiorespiratory fitness using the VO2 submaximal test on the recumbent stepper.

Non-smokers; Smokers

Nicotine dependence GENETIC

DNA sequencing for 20-25 subjects out of the whole sample will be performed. Sanger sequencing to all subjects will also be performed to identify related genes

Smokers

Nicotine and cotinine serum levels DIAGNOSTIC_TEST

Cotinine serum level which is a major metabolite of nicotine and the preferred biomarker for measuring tobacco use will be measured together with nicotine levels using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).

Non-smokers; Smokers

Smoking BEHAVIORAL

Surveys that measure nicotine dependence and smoking behavior

Smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with MS who are current or non smokers and who are able to ambulate independently with or without an assistive device

You may qualify if:

• Confirmed diagnosis of MS from a neurologist using the McDonald diagnostic criteria
• Ability to ambulate independently with or without an assistive device
• Current, previous, and nonsmokers
• Age ≥ 18 years
• Ability to give informed consent.

You may not qualify if:

• A neurological disease other than MS
• Orthopedic problems or other conditions that may significantly interfere with testing
• Uncorrected vision loss
• Acute ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
• Uncontrolled blood pressure with medication (BP\>190/110mmHg).

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Cell Therapy Center

Amman, Jordan

Location

Related Publications (16)

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  PMID: 26459151 BACKGROUND

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  PMID: 25867464 BACKGROUND

• Alrouji M, Manouchehrinia A, Gran B, Constantinescu CS. Effects of cigarette smoke on immunity, neuroinflammation and multiple sclerosis. J Neuroimmunol. 2019 Apr 15;329:24-34. doi: 10.1016/j.jneuroim.2018.10.004. Epub 2018 Oct 9.

  PMID: 30361070 BACKGROUND

• Braley TJ, Chervin RD. A practical approach to the diagnosis and management of sleep disorders in patients with multiple sclerosis. Ther Adv Neurol Disord. 2015 Nov;8(6):294-310. doi: 10.1177/1756285615605698.

  PMID: 26600873 BACKGROUND

• Purani H, Friedrichsen S, Allen AM. Sleep quality in cigarette smokers: Associations with smoking-related outcomes and exercise. Addict Behav. 2019 Mar;90:71-76. doi: 10.1016/j.addbeh.2018.10.023. Epub 2018 Oct 17.

  PMID: 30368021 BACKGROUND

• Dugas EN, Sylvestre MP, O'Loughlin EK, Brunet J, Kakinami L, Constantin E, O'Loughlin J. Nicotine dependence and sleep quality in young adults. Addict Behav. 2017 Feb;65:154-160. doi: 10.1016/j.addbeh.2016.10.020. Epub 2016 Oct 25.

  PMID: 27816041 BACKGROUND

• Chen LJ, Steptoe A, Chen YH, Ku PW, Lin CH. Physical activity, smoking, and the incidence of clinically diagnosed insomnia. Sleep Med. 2017 Feb;30:189-194. doi: 10.1016/j.sleep.2016.06.040. Epub 2016 Nov 25.

  PMID: 28215247 BACKGROUND

• Veauthier C, Paul F. Sleep disorders in multiple sclerosis and their relationship to fatigue. Sleep Med. 2014 Jan;15(1):5-14. doi: 10.1016/j.sleep.2013.08.791. Epub 2013 Nov 15.

  PMID: 24360534 BACKGROUND

• Jaehne A, Unbehaun T, Feige B, Lutz UC, Batra A, Riemann D. How smoking affects sleep: a polysomnographical analysis. Sleep Med. 2012 Dec;13(10):1286-92. doi: 10.1016/j.sleep.2012.06.026. Epub 2012 Sep 28.

  PMID: 23026505 BACKGROUND

• Newland P, Flick L, Salter A, Dixon D, Jensen MP. The link between smoking status and co-morbid conditions in individuals with multiple sclerosis (MS). Disabil Health J. 2017 Oct;10(4):587-591. doi: 10.1016/j.dhjo.2017.03.005. Epub 2017 Mar 23.

  PMID: 28351749 BACKGROUND

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  PMID: 25246792 BACKGROUND

• El-Salem K, Al-Shimmery E, Horany K, Al-Refai A, Al-Hayk K, Khader Y. Multiple sclerosis in Jordan: A clinical and epidemiological study. J Neurol. 2006 Sep;253(9):1210-6. doi: 10.1007/s00415-006-0203-2. Epub 2006 Apr 28.

  PMID: 16649096 BACKGROUND

• Manouchehrinia A, Weston M, Tench CR, Britton J, Constantinescu CS. Tobacco smoking and excess mortality in multiple sclerosis: a cohort study. J Neurol Neurosurg Psychiatry. 2014 Oct;85(10):1091-5. doi: 10.1136/jnnp-2013-307187. Epub 2014 Feb 25.

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• Raja M, Garg A, Yadav P, Jha K, Handa S. Diagnostic Methods for Detection of Cotinine Level in Tobacco Users: A Review. J Clin Diagn Res. 2016 Mar;10(3):ZE04-6. doi: 10.7860/JCDR/2016/17360.7423. Epub 2016 Mar 1.

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  PMID: 19363894 BACKGROUND

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  PMID: 26223473 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA sequencing for 20-25 subjects out of the whole sample will be performed. Sanger sequencing to all subjects will also be performed to identify related genes.

MeSH Terms

Conditions

Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Cigarette Smoking; Motor Activity

Interventions

Exercise; Nicotine Chewing Gum; Smoking Devices

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mayis Aldughmi, PhD

  University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 16, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

JO (1)