Obstructive Sleep ApneaNCT02539264
Impact of Smoking, Benzodiazepine (BZD) Use and Obesity on Severe Obstructive Sleep Apnea (sOSA)
An observational study of Obstructive Sleep Apnea and Obesity, run by Astes.
Trial summary
In this study the investigators will analyze the influence of smoking, benzodizepine use, and obesity among patients with severe Obstructive Sleep Apnea (sOSA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity, Smoking
- What is being tested?
- Smoking, Obesity and Benzodiazepine use
- How many people
- 920 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge
Who may be able to join
- All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge
Who cannot join
- None
About this study
Official title: Impact of Smoking, BZD and Obesity on Severe Obstructive Sleep Apnea (sOSA)
In this study the investigators will analyze the influence of smoking, benzodizepine use, and obesity among patients with severe Obstructive Sleep Apnea (sOSA).
Read the detailed description
This study is a retrospective study. Patients enrolled: all patients with a PSG (polysomnography) between 1st January 2014 and 30th June 2015.
First analysis: influence of smoking, benzodiazepine use, and obesity on the AHI (Apnea Hypopnea Index: the number of apnea and hypopnea per hour of sleep).
Second analysis: only among patients with sOSA: influence of smoking, benzodiazepine use, and obesity on sleep fragmentation and night oximetry.
- Conditions
- Obstructive Sleep Apnea, Obesity, Smoking
- Being tested
- Smoking, Obesity, Benzodiazepine use
- Keywords
- All patients registered for A PSG, polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokingOther
Influence of smoking on parameters derived from overnight PSG
ObesityOther
Influence of obesity on parameters derived from overnight PSG
Benzodiazepine useOther
Influence of benzodiazepine use on parameters derived from overnight PSG
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
Apnea Hypopnea Index (AHI) is defined as the number of apnea and hypopnea per hour of sleep. It is the major determinant of the severity of OSA.
Measured: 1 day
Secondary outcomes (2)
Sleep fragmentation defined by the percentage of time spent in each of the four stades of sleep (Stade 1, Stade 2, Slow wave sleep and Rapid Eye Movements)
Are smoking and/or obesity a risk factor for sleep fragmentation?
Measured: 1 day
Time spent under 90% of SpO2 during the night
Are smoking and/or obesity a risk factor for oxygen desaturation (< 90% SpO2) during the night?
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJul 2015
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, FCCP, Astes
- Investigators
- Eric DEFLANDRE, MD, FCCP, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539264
- Sponsor's protocol ID
- DEES-OSA
- Status last verified
- Jan 2016
- First submitted
- 29 Aug 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Smoking, BZD and Obesity on Severe Obstructive Sleep Apnea (sOSA)
- ClinicalTrials.gov ID
- NCT02539264
- Acronym / sponsor ID
- DEES-OSA
- Conditions
- Obstructive Sleep Apnea, Obesity, Smoking
- Keywords
- All patients registered for A PSG, polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Sep 2015 (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.
In this study the investigators will analyze the influence of smoking, benzodizepine use, and obesity among patients with severe Obstructive Sleep Apnea (sOSA).
Detailed description
This study is a retrospective study. Patients enrolled: all patients with a PSG (polysomnography) between 1st January 2014 and 30th June 2015.
First analysis: influence of smoking, benzodiazepine use, and obesity on the AHI (Apnea Hypopnea Index: the number of apnea and hypopnea per hour of sleep).
Second analysis: only among patients with sOSA: influence of smoking, benzodiazepine use, and obesity on sleep fragmentation and night oximetry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge
Key inclusion criteria (1 listed)
- All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge
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 |
|---|---|---|
| SmokingInfluence of smoking on parameters derived from overnight PSG | Other | – |
| ObesityInfluence of obesity on parameters derived from overnight PSG | Other | – |
| Benzodiazepine useInfluence of benzodiazepine use on parameters derived from overnight PSG | Other | – |
Primary outcome
Apnea Hypopnea Index
Time frame: 1 day
Apnea Hypopnea Index (AHI) is defined as the number of apnea and hypopnea per hour of sleep. It is the major determinant of the severity of OSA.
2 secondary outcomes
Sleep fragmentation defined by the percentage of time spent in each of the four stades of sleep (Stade 1, Stade 2, Slow wave sleep and Rapid Eye Movements)
Time frame: 1 day
Time spent under 90% of SpO2 during the night
Time frame: 1 day
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 6 Jan 2016.
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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, FCCP principal investigator
Astes
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Obesity, 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 6 Jan 2016. 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?
Apnea Hypopnea Index (time frame: 1 day). 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 6 Jan 2016.