Multiple SclerosisSmoke-MSNCT05046535
The Effect of Cigarette Smoke on Sleep Quality and Physical Activity in People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Sleep quality and physical activity, Nicotine dependence and Nicotine and cotinine serum levels
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 72 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2021to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with MS who are current or non smokers and who are able to ambulate independently with or without an assistive device
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Prevalence of Cigarette Smoke in Jordan
29% of the adult population in Jordan are smokers, making it the highest rate in the middle east. According to the 2017 WHO report, smoking prevalence is increasing in the eastern Mediterranean region, in which Jordan is the leading country across the middle east with the worst ratings in cigarette smoke. Another recent study in 2019 conducted by the Jordanian government in collaboration with the WHO, showed that eight out of ten men in Jordan regularly smoke nicotine and consume around 23 cigarettes per day. Therefore, the percentage of Jordanian men who smoke increased up to 66% and 17% for Jordanian women, making these rates dangerously high.
Impact of Cigarette Smoke
Cigarette smoke accounts for six million deaths annually worldwide and is a major cause of morbidity, increasing the risk of developing cancer, cardiovascular disease, and pulmonary infections. Cigarette smoke has been found to be associated with sleep disturbances in healthy adult smokers. In addition, those who smoke cigarettes have less physical endurance and performance, decreased muscle strength and flexibility affecting their overall physical fitness and health.
Nicotine in cigarette smoke may disrupt sleep quality through several mechanisms. The release of neurotransmitters that disrupts the normal sleep-wake cycle such as dopamine and serotonin, disruption in the circadian rhythms that may develop chronic conditions such as depression, and craving nicotine during the night due to nicotine dependence may all disrupts a cigarette smoker night of sleep. Carbon monoxide and other toxins found in cigarette smoke affects the binding of oxygen to red blood cells affecting the delivery of oxygen to active muscles, heart, and lungs which might explain the low physical fitness level of smokers.
Sleep Quality in Multiple Sclerosis
Multiple Sclerosis (MS) is a neurodegenerative disease characterized by the destruction of myelin in the central nervous system. People with MS often present with a variety of symptoms including sleep disturbances that affects around 70 % of these individuals. Sleep disorders such as obstructive sleep apnea and insomnia are also commonly seen among this population. Poor sleep quality affect people with MS daily physical function, and may worsen other symptoms such as depression, pain, and fatigue. Sleep disturbances in MS may be due to primary factors that result from lesions in brain areas controlling sleep/wake cycles, or secondary factors which are due to medication side-effects or symptoms that accompany MS such as pain, fatigue, depression, and bowl and bladder problems.
Smoking and Multiple Sclerosis
Research in the area of cigarette smoke and MS suggests that smoking increases the risk of developing MS, increase the number of relapses and disease severity among people with MS, fasten their transfer into more progressive forms, reduce the effectiveness of their disease-modifying therapies, and worsen symptoms such as pain, motor deficits, and cognitive impairments. It is suggested that cigarette smoke alter the immune response and induce inflammatory changes in people with MS which might explain the host of negative effects it has on MS disease status.
Genetics and Smoking
Current evidence suggests that genes play a major role in smoking behavior and that certain genetic differences greatly affects nicotine dependence among healthy individuals. These genes can ultimately affect how an individual initiate and quit smoking. There is also evidence that showed specific genes are associated with an increased risk of developing smoking related diseases such as cardiovascular diseases. Therefore, it would be interesting to explore genetic predisposition to nicotine dependence among PwMS. Understanding the effect of genes on cigarette smoke behavior will greatly influence the decision making on effective smoking cessation treatments in the future.
Significance of Study
As current evidence from the healthy smoking population suggests those who smoke cigarettes have more sleep disturbances compared to non-smokers, people with MS who smoke cigarettes may have poorer sleep quality and higher risk of developing sleep disorders such as obstructive sleep apnea. In addition, being physical inactive negatively influence the rehabilitation process of people with MS. It affects their participation in therapy and can result in deconditioning of their muscles and joints worsening their symptoms. It can also affect other quality of life indices including their social interpersonal relationships and employment rates. Despite the evidence on the effects of cigarette smoke in people with MS, to our knowledge, no previous study has explored the relationship between smoking status, sleep quality, and physical activity in people with MS.
Considering the high prevalence of cigarette smoke in Jordan and its negative effects on the overall well-being of individuals specially people with MS, It is crucial to explore its relationship with common symptoms among a sample of Jordanian people with MS. Another area of this project that the researchers are interested to explore is the genetic susceptibility of people with MS to cigarette smoke, specifically to nicotine dependence.
Although this has been studied before in health smokers, no previous study has explored this among people with MS. Understanding the role genes play on smoking behavior among PwMS will guide future large scale studies to further explore this relationship and eventually provide guidance to smoking cessation programs.
The researchers of this project believe that findings from this study will:
- Shed the light on a major public health problem and its association with health-related outcomes in PwMS.
- Increase awareness on the negative effects of cigarette smoke among PwMS, health-care providers, and researchers.
- Increase awareness on the importance of physical activity among PwMS as well as health care providers to promote physical activity among their clients.
- Shed the light on the important effect of the genomic material on the behaviors of adults which will influence cigarette smoke treatment and prevention options
- Provide the base for future studies to explore management options such as smoking cessation programs and physical activity for the aim to improve sleep quality in PwMS.
- Generate recommendations among health care providers to promote sleep health among PwMS and policy makers to enforce stricter regulations on promoting, using, and selling cigarettes in Jordan and the World.
- Conditions
- Multiple Sclerosis
- Being tested
- Sleep quality and physical activity, Nicotine dependence, Nicotine and cotinine serum levels, Smoking
- Keywords
- Sleep quality, Cigarette Smoking, Physical Activity, Secondhand smoke
- Medical subject headings
- Multiple Sclerosis, Sleep Initiation and Maintenance Disorders, Cigarette Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep quality and physical activityBehavioural
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.
Nicotine dependenceGenetic
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
Nicotine and cotinine serum levelsDiagnostic 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).
SmokingBehavioural
Surveys that measure nicotine dependence and smoking behavior
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sleep quality and physical activity; Diagnostic Test: Nicotine and cotinine serum levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Genetic predisposition to nicotine dependence and other blood tests
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. ELISA oxidative stress microarray will also be performed to all subjects. Vitamin D levels will also be detected from the subject's blood sample. Blood samples will be collected, stored, and analyzed at the CTC.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayis Aldughmi, University of Jordan
- Investigators
- Mayis Aldughmi, PhD, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046535
- Sponsor's protocol ID
- 2021-2020/26
- Acronym
- Smoke-MS
- Status last verified
- Jun 2024
- First submitted
- 5 Sep 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hedstrom AK, Olsson T, Alfredsson L. Smoking is a major preventable risk factor for multiple sclerosis. Mult Scler. 2016 Jul;22(8):1021-6. doi: 10.1177/1352458515609794. Epub 2015 Oct 12.
PubMed 26459151Correale J, Farez MF. Smoking worsens multiple sclerosis prognosis: two different pathways are involved. J Neuroimmunol. 2015 Apr 15;281:23-34. doi: 10.1016/j.jneuroim.2015.03.006. Epub 2015 Mar 6.
PubMed 25867464Alrouji 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.
PubMed 30361070Braley 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.
PubMed 26600873Purani 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.
PubMed 30368021Dugas 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.
PubMed 27816041Chen 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.
PubMed 28215247Veauthier 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.
PubMed 24360534Jaehne 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.
PubMed 23026505Newland 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.
PubMed 28351749Ozcan ME, Ince B, Bingol A, Erturk S, Altinoz MA, Karadeli HH, Kocer A, Asil T. Association between smoking and cognitive impairment in multiple sclerosis. Neuropsychiatr Dis Treat. 2014 Sep 10;10:1715-9. doi: 10.2147/NDT.S68389. eCollection 2014.
PubMed 25246792El-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.
PubMed 16649096Manouchehrinia 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.
PubMed 24569687Raja 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.
PubMed 27135020Davies GE, Soundy TJ. The genetics of smoking and nicotine addiction. S D Med. 2009;Spec No:43-9.
PubMed 19363894
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cigarette Smoke on Sleep Quality and Physical Activity in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05046535
- Acronym / sponsor ID
- Smoke-MS / 2021-2020/26
- Conditions
- Multiple Sclerosis
- Keywords
- Sleep quality, Cigarette Smoking, Physical Activity, Secondhand smoke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Prevalence of Cigarette Smoke in Jordan
29% of the adult population in Jordan are smokers, making it the highest rate in the middle east. According to the 2017 WHO report, smoking prevalence is increasing in the eastern Mediterranean region, in which Jordan is the leading country across the middle east with the worst ratings in cigarette smoke. Another recent study in 2019 conducted by the Jordanian government in collaboration with the WHO, showed that eight out of ten men in Jordan regularly smoke nicotine and consume around 23 cigarettes per day. Therefore, the percentage of Jordanian men who smoke increased up to 66% and 17% for Jordanian women, making these rates dangerously high.
Impact of Cigarette Smoke
Cigarette smoke accounts for six million deaths annually worldwide and is a major cause of morbidity, increasing the risk of developing cancer, cardiovascular disease, and pulmonary infections. Cigarette smoke has been found to be associated with sleep disturbances in healthy adult smokers. In addition, those who smoke cigarettes have less physical endurance and performance, decreased muscle strength and flexibility affecting their overall physical fitness and health.
Nicotine in cigarette smoke may disrupt sleep quality through several mechanisms. The release of neurotransmitters that disrupts the normal sleep-wake cycle such as dopamine and serotonin, disruption in the circadian rhythms that may develop chronic conditions such as depression, and craving nicotine during the night due to nicotine dependence may all disrupts a cigarette smoker night of sleep. Carbon monoxide and other toxins found in cigarette smoke affects the binding of oxygen to red blood cells affecting the delivery of oxygen to active muscles, heart, and lungs which might explain the low physical fitness level of smokers.
Sleep Quality in Multiple Sclerosis
Multiple Sclerosis (MS) is a neurodegenerative disease characterized by the destruction of myelin in the central nervous system. People with MS often present with a variety of symptoms including sleep disturbances that affects around 70 % of these individuals. Sleep disorders such as obstructive sleep apnea and insomnia are also commonly seen among this population. Poor sleep quality affect people with MS daily physical function, and may worsen other symptoms such as depression, pain, and fatigue. Sleep disturbances in MS may be due to primary factors that result from lesions in brain areas controlling sleep/wake cycles, or secondary factors which are due to medication side-effects or symptoms that accompany MS such as pain, fatigue, depression, and bowl and bladder problems.
Smoking and Multiple Sclerosis
Research in the area of cigarette smoke and MS suggests that smoking increases the risk of developing MS, increase the number of relapses and disease severity among people with MS, fasten their transfer into more progressive forms, reduce the effectiveness of their disease-modifying therapies, and worsen symptoms such as pain, motor deficits, and cognitive impairments. It is suggested that cigarette smoke alter the immune response and induce inflammatory changes in people with MS which might explain the host of negative effects it has on MS disease status.
Genetics and Smoking
Current evidence suggests that genes play a major role in smoking behavior and that certain genetic differences greatly affects nicotine dependence among healthy individuals. These genes can ultimately affect how an individual initiate and quit smoking. There is also evidence that showed specific genes are associated with an increased risk of developing smoking related diseases such as cardiovascular diseases. Therefore, it would be interesting to explore genetic predisposition to nicotine dependence among PwMS. Understanding the effect of genes on cigarette smoke behavior will greatly influence the decision making on effective smoking cessation treatments in the future.
Significance of Study
As current evidence from the healthy smoking population suggests those who smoke cigarettes have more sleep disturbances compared to non-smokers, people with MS who smoke cigarettes may have poorer sleep quality and higher risk of developing sleep disorders such as obstructive sleep apnea. In addition, being physical inactive negatively influence the rehabilitation process of people with MS. It affects their participation in therapy and can result in deconditioning of their muscles and joints worsening their symptoms. It can also affect other quality of life indices including their social interpersonal relationships and employment rates. Despite the evidence on the effects of cigarette smoke in people with MS, to our knowledge, no previous study has explored the relationship between smoking status, sleep quality, and physical activity in people with MS.
Considering the high prevalence of cigarette smoke in Jordan and its negative effects on the overall well-being of individuals specially people with MS, It is crucial to explore its relationship with common symptoms among a sample of Jordanian people with MS. Another area of this project that the researchers are interested to explore is the genetic susceptibility of people with MS to cigarette smoke, specifically to nicotine dependence.
Although this has been studied before in health smokers, no previous study has explored this among people with MS. Understanding the role genes play on smoking behavior among PwMS will guide future large scale studies to further explore this relationship and eventually provide guidance to smoking cessation programs.
The researchers of this project believe that findings from this study will:
- Shed the light on a major public health problem and its association with health-related outcomes in PwMS.
- Increase awareness on the negative effects of cigarette smoke among PwMS, health-care providers, and researchers.
- Increase awareness on the importance of physical activity among PwMS as well as health care providers to promote physical activity among their clients.
- Shed the light on the important effect of the genomic material on the behaviors of adults which will influence cigarette smoke treatment and prevention options
- Provide the base for future studies to explore management options such as smoking cessation programs and physical activity for the aim to improve sleep quality in PwMS.
- Generate recommendations among health care providers to promote sleep health among PwMS and policy makers to enforce stricter regulations on promoting, using, and selling cigarettes in Jordan and the World.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | Behavioral: Sleep quality and physical activity, Genetic: Nicotine dependence, Diagnostic Test: Nicotine and cotinine serum levels, Behavioral: SmokingIndividuals 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. |
| Non-smokers | – | Behavioral: Sleep quality and physical activity, Diagnostic Test: Nicotine and cotinine serum levelsIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with MS who are current or non smokers and who are able to ambulate independently with or without an assistive device
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep quality and physical activitySelf-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. | Behavioural | Non-smokers, Smokers |
| Nicotine dependenceDNA 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 | Genetic | Smokers |
| Nicotine and cotinine serum levelsCotinine 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). | Diagnostic test | Non-smokers, Smokers |
| SmokingSurveys that measure nicotine dependence and smoking behavior | Behavioural | Smokers |
Primary outcome
Nicotine and cotinine serum levels
Time frame: 6 months
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.
Sleep quality
Time frame: 6 months
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.
Physical activity and cardiorespiratory fitness
Time frame: 6 months
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.
1 secondary outcome
Genetic predisposition to nicotine dependence and other blood tests
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 26459151Hedstrom AK, Olsson T, Alfredsson L. Smoking is a major preventable risk factor for multiple sclerosis. Mult Scler. 2016 Jul;22(8):1021-6. doi: 10.1177/1352458515609794. Epub 2015 Oct 12.
- Background: PubMed 25867464Correale J, Farez MF. Smoking worsens multiple sclerosis prognosis: two different pathways are involved. J Neuroimmunol. 2015 Apr 15;281:23-34. doi: 10.1016/j.jneuroim.2015.03.006. Epub 2015 Mar 6.
- Background: PubMed 30361070Alrouji 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.
- Background: PubMed 26600873Braley 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.
- Background: PubMed 30368021Purani 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.
- Background: PubMed 27816041Dugas 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.
- Background: PubMed 28215247Chen 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.
- Background: PubMed 24360534Veauthier 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.
- Background: PubMed 23026505Jaehne 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.
- Background: PubMed 28351749Newland 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.
- Background: PubMed 25246792Ozcan ME, Ince B, Bingol A, Erturk S, Altinoz MA, Karadeli HH, Kocer A, Asil T. Association between smoking and cognitive impairment in multiple sclerosis. Neuropsychiatr Dis Treat. 2014 Sep 10;10:1715-9. doi: 10.2147/NDT.S68389. eCollection 2014.
- Background: PubMed 16649096El-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.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayis Aldughmi, PhD principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine and cotinine serum levels (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046535, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.