Obstructive Sleep ApneaNCT03574740
Influence of Tobacco Smoking on the Development of Obstructive Sleep Apnea (OSA)
An observational study of Obstructive Sleep Apnea and Tobacco Use, run by Astes.
Trial summary
The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Tobacco Use
- What is being tested?
- Tobacco Smoking
- How many people
- 1,298 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 20 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography. For these patients, the influence of tobacco smoking on the development of OSA will be studied.
Who may be able to join
- All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography
Who cannot join
- None
About this study
The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).
Read the detailed description
The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).
Statistical analysis will be performed on this retrospective population to determine in tobacco smoking could influence the development of OSA.
- Conditions
- Obstructive Sleep Apnea, Tobacco Use
- Being tested
- Tobacco Smoking
- Medical subject headings
- Sleep Apnea, Obstructive, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco SmokingOther
Influence of Tobacco Smoking on the development of OSA
| Study group | Role | What they receive |
|---|---|---|
| Entire population | All patients included in this retrospective study. These patients were analyzed following their tobacco smoking habits. Receives: Other: Tobacco Smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive Sleep Apnea (OSA)
Diagnosis of OSA based on a polysomnography recording
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, PhD, FCCP, Astes
- Investigators
- Eric Deflandre, MD, PhD, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574740
- Sponsor's protocol ID
- Tobacco-OSA
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Tobacco Smoking on the Development of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT03574740
- Acronym / sponsor ID
- Tobacco-OSA
- Conditions
- Obstructive Sleep Apnea, Tobacco Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,298 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 2 Jul 2018 (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.
The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).
Detailed description
The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).
Statistical analysis will be performed on this retrospective population to determine in tobacco smoking could influence the development of OSA.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entire population | – | Other: Tobacco SmokingAll patients included in this retrospective study. These patients were analyzed following their tobacco smoking habits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography. For these patients, the influence of tobacco smoking on the development of OSA will be studied.
Key inclusion criteria (1 listed)
- All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Tobacco SmokingInfluence of Tobacco Smoking on the development of OSA | Other | Entire population |
Primary outcome
Obstructive Sleep Apnea (OSA)
Time frame: 1 month
Diagnosis of OSA based on a polysomnography recording
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 3 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Eric Deflandre, MD, PhD principal investigator
Astes
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Tobacco Use, run by Astes.
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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Obstructive Sleep Apnea (OSA) (time frame: 1 month). 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 3 Jul 2018.