NCT02539264

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
920

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

August 29, 2015

Last Update Submit

January 5, 2016

Conditions

Obstructive Sleep ApneaObesitySmoking

Keywords

All patients registered for A PSGpolysomnography

Outcome Measures

Primary Outcomes (1)

  • 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

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)

    1 day

  • Time spent under 90% of SpO2 during the night

    1 day

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesitySmoking

Interventions

Smoking DevicesAdiposity

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and AgricultureBody Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Study Officials

  • Eric DEFLANDRE, MD, FCCP

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FCCP

Study Record Dates

First Submitted

August 29, 2015

First Posted

September 3, 2015

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01