Vasovagal SyncopeNCT02949804
Relation Between Vasovagal Tendency and Smoking Among University Students
An observational study of Vasovagal Syncope and Smoke Inhalation, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
Trial summary
Almost everyone is aware these days is aware about the risk of smoking. Still many people start this habit specially in early life and during college year. We aim to investigate in this study if there is a drive to smoke in people with vasovagal tendency to improve their symptoms, even if not aware of this. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasovagal Syncope, Smoke Inhalation
- What is being tested?
- Comparison between two groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteJordan
- Study dates
- Dec 2016to Mar 2018
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Students at the university or college
Who may be able to join
- College students who agree to participate in the questionnaire
Who cannot join
- Unable or does not consent to fill the form
Trial locations and contacts
1 site in 1 country.
About this study
Almost everyone is aware these days is aware about the risk of smoking. Still many people start this habit specially in early life and during college year. We aim to investigate in this study if there is a drive to smoke in people with vasovagal tendency to improve their symptoms, even if not aware of this. Vasovoagal symptoms are common and include dizziness, smoking, sweating, abdominal pain, fatigue and syncope. Some studies have shown correlation between smoking and a positive tilt table test which is indicative of vasovagal tendency. By collecting the information regarding smoking habit and vasovagal symptoms analysis can be done to see if there is correlation between these two factors
Read the detailed description
Methods
A questionnaire will be conducted among university students to investigate the tendency toward vasovagal symptoms and also smoking habits. Statistical correlation will be subsequently conducted to see if there is correlation between those two problems (vasovagal symptoms and smoking)
Study criteria inclusion
Benefit to the patient:
There is no direct benefit for participation in the study. The information obtained may help in the future to find factors that increase smoking and being aware of these factors may help in controlling the habit of smoking.
- Conditions
- Vasovagal Syncope, Smoke Inhalation
- Being tested
- Comparison between two groups
- Medical subject headings
- Syncope, Vasovagal, Smoke Inhalation Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between two groupsBehavioural
Comparison will be made between smokers and non smokers regarding vasovagal tendency
| Study group | Role | What they receive |
|---|---|---|
| Smoker | Vasovagal tendency will be compared among smokers and non smokers Receives: Behavioral: Comparison between two groups | |
| Non-smokers | Vasovagal tendency will be compared among smokers and non smokers Receives: Behavioral: Comparison between two groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vasovagal tenancy in smokers and non smokers
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 posted31 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasovagal SyncopeStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Munir Al Zaqqa, MD, Principal investigator, Jordan Collaborating Cardiology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949804
- Sponsor's protocol ID
- 2
- Status last verified
- Mar 2018
- First submitted
- 26 Oct 2016
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Once data is collected it will be shared with researchers after making individuals anonymous
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Vasovagal Tendency and Smoking Among University Students
- ClinicalTrials.gov ID
- NCT02949804
- Acronym / sponsor ID
- 2
- Conditions
- Vasovagal Syncope, Smoke Inhalation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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.
Almost everyone is aware these days is aware about the risk of smoking. Still many people start this habit specially in early life and during college year. We aim to investigate in this study if there is a drive to smoke in people with vasovagal tendency to improve their symptoms, even if not aware of this. Vasovoagal symptoms are common and include dizziness, smoking, sweating, abdominal pain, fatigue and syncope. Some studies have shown correlation between smoking and a positive tilt table test which is indicative of vasovagal tendency. By collecting the information regarding smoking habit and vasovagal symptoms analysis can be done to see if there is correlation between these two factors
Detailed description
Methods
A questionnaire will be conducted among university students to investigate the tendency toward vasovagal symptoms and also smoking habits. Statistical correlation will be subsequently conducted to see if there is correlation between those two problems (vasovagal symptoms and smoking)
Study criteria inclusion
Benefit to the patient:
There is no direct benefit for participation in the study. The information obtained may help in the future to find factors that increase smoking and being aware of these factors may help in controlling the habit of smoking.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoker | – | Behavioral: Comparison between two groupsVasovagal tendency will be compared among smokers and non smokers |
| Non-smokers | – | Behavioral: Comparison between two groupsVasovagal tendency will be compared among smokers and non smokers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students at the university or college
Key inclusion criteria (1 listed)
- College students who agree to participate in the questionnaire
Key exclusion criteria (1 listed)
- Unable or does not consent to fill the form
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 |
|---|---|---|
| Comparison between two groupsComparison will be made between smokers and non smokers regarding vasovagal tendency | Behavioural | Non-smokers, Smoker |
Primary outcome
Incidence of vasovagal tenancy in smokers and non smokers
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 13 Mar 2018.
- Individual participant dataSharing planned: Undecided. Once data is collected it will be shared with researchers after making individuals anonymous
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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.
Munir Al Zaqqa, MD principal investigator
Jordan Collaborating Cardiology Group
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 Vasovagal Syncope and Smoke Inhalation, run by Jordan Collaborating Cardiology Group 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 1 inclusion and 1 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 13 Mar 2018. 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?
Incidence of vasovagal tenancy in smokers and non smokers (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2018.