NCT01135303

Brief Summary

The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in adults is now well documented as well as its cardiovascular repercussions. Previous studies showed a conclusive link between SAHS and severe cardiovascular diseases such as hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health issue in adults. In this context, early detection of such a disease is crucial if the management is tailored to the patient, the practitioner's choice of therapy moving towards continuous positive airway pressure (CPAP) or mandibular advancement device. The detection is based on full nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold standard but it is a time consuming and costly examination. Polygraphic recording is a test that allows simplified the diagnosis of severe patients, but may not be sufficient for mild form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation of a technique for identifying patients most at risk to either limit the number of polysomnographic examination is requested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

February 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

Enrollment Period

1.9 years

First QC Date

May 25, 2010

Last Update Submit

July 20, 2011

Conditions

Sleep Apnea Syndromes

Keywords

Sleep Apnea SyndromesPolysomnographyHolter ECGThoracic impedanceHeart rate variability

Outcome Measures

Primary Outcomes (1)

  • Sleep apnea hypopnea syndrome

    Apnea hypopnea index higher than 15, evaluated by polysomnography.

    Day 1

Study Arms (1)

VistaO2 device

EXPERIMENTAL

This device combines the transcutaneous oxyhemoglobin saturation (allowing to compute the oxyhemoglobin desaturation index), the slow variations in heart rate and an index of nocturnal respiratory events calculated by analyzing the movements of the chest performed by chest impedance variations.

Device: VistaO2 device

Interventions

VistaO2 deviceDEVICE

Full night VistaO2 device monitoring synchronized with the gold standard polysomnography.

Also known as: VistaO2 : ECG Holter recorder (Novacor, Rueil-Malmaison, France).
VistaO2 device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sleep apnea hypopnea syndrome suspicion
  • written consent

You may not qualify if:

  • pacemaker
  • diabetes
  • atrial fibrillation
  • electrode allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital TENON - APHP

Paris, 75000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • Chouchou F, Poupard L, Philippe C, Court-Fortune I, Barthelemy JC, Roche F. Thoracic impedance, in association with oximetry, in a multi-modal ECG Holter system is useful for screening sleep disordered breathing. Int J Cardiol. 2013 Feb 10;163(1):100-2. doi: 10.1016/j.ijcard.2012.06.082. Epub 2012 Jul 16. No abstract available.

    PMID: 22805548DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Frédéric ROCHE, MD-PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2010

First Posted

June 2, 2010

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 21, 2011

Record last verified: 2011-07

Locations

FR(2)