Influence of Tobacco Smoking on the Development of Obstru... | NCT03574740

Studies
Influence of Tobacco Smoking on the Development of Obstructive Sleep Apnea (OSA)

NCT03574740

Sponsor

Astes

Status

Completed

Last Update Posted

Jul 3, 2018Actual

Enrollment

1,298Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea
Tobacco Use

Interventions

Tobacco Smoking

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jun 20, 2018Actual

First Submitted Date

Jun 21, 2018

First Submission Date that Met QC Criteria

Jun 21, 2018

First Posted Date

Jul 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2018

Last Update Posted Date

Jul 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,298Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Entire population		All patients included in this retrospective study. These patients were analyzed following their tobacco smoking habits.	Other: Tobacco Smoking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tobacco Smoking	Other	Influence of Tobacco Smoking on the development of OSA	Entire population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obstructive Sleep Apnea (OSA)	Diagnosis of OSA based on a polysomnography recording	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Eric Deflandre, MD, PhD	Astes	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D064424	Tobacco Use

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074602	Smoking Devices

Ancestor Terms

ID	Term
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided