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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539264
• Other study ID #: DEES-OSA
• Status: Completed
• Phase: N/A
• First received: August 29, 2015
• Last updated: January 5, 2016
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Astes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Smoking

Intervention

Other:
• Smoking
Influence of smoking on parameters derived from overnight PSG
• Obesity
Influence of obesity on parameters derived from overnight PSG
• Benzodiazepine use
Influence of benzodiazepine use on parameters derived from overnight PSG

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day	Yes
Secondary	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?	1 day	Yes
Secondary	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?	1 day	Yes