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

Completed

• Conditions: Obesity; Smoking; Obstructive Sleep Apnea

• Registration Number: NCT02539264
• Lead Sponsor: Astes

Brief Summary

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Study First Submitted: 2015-08-29
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 920

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	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.

Secondary Outcome Measures

Name	Time	Method
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)	1 day	Are smoking and/or obesity a risk factor for sleep fragmentation?
Time spent under 90% of SpO2 during the night	1 day	Are smoking and/or obesity a risk factor for oxygen desaturation (\< 90% SpO2) during the night?