Impact of Smoking, Benzodiazepine (BZD) Use and Obesity on Severe Obstructive Sleep Apnea (sOSA)

January 5, 2016 updated by: Eric DEFLANDRE, MD, FCCP, Astes

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge

Description

Inclusion Criteria:

  • All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Are smoking and/or obesity a risk factor for sleep fragmentation?
1 day
Time spent under 90% of SpO2 during the night
Time Frame: 1 day
Are smoking and/or obesity a risk factor for oxygen desaturation (< 90% SpO2) during the night?
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 29, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEES-OSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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