Back to results

Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization (NIV-OHS)

Primary Purpose

Obesity-Hypoventilation Syndrome (OHS)

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

About this trial

This is an interventional treatment trial for Obesity-Hypoventilation Syndrome (OHS)

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient male or female, aged 20 to 75 years
Patient with a OHS in stable condition, with a BMI> 32 kg/m2 and a PaCO2> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation
Patient affiliated to a social security insurance
Having given its written informed consent to participate to the study

Exclusion Criteria:

Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70%
Patients suffering from heart failure with periodic breathing
Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities
Unbalanced Psychiatric Diseases
Patients with a respiratory decompensation the month preceding the study
Patients not autonomous in the use of the NIV
Pacemaker patients, constituting a contraindication to magnetic stimulation
Sensitive subjects, in accordance with article L 1121-6 of the French Public Health Code
Patients with long term by steroids or other anti-inflammatory drugs

Sites / Locations

Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU GrenobleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

patients will benefit from a complete polysomnography under NIV

settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas

Outcomes

Primary Outcome Measures

Diurnal PaCO2

Secondary Outcome Measures

Full Information

NCT ID

NCT00603096

First Posted

January 15, 2008

Last Updated

January 15, 2008

Sponsor

Tyco Healthcare Group

1. Study Identification

Unique Protocol Identification Number

NCT00603096

Brief Title

Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization

Acronym

NIV-OHS

Official Title

Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2006 (undefined)

Primary Completion Date

June 2008 (Anticipated)

Study Completion Date

June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tyco Healthcare Group

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.

Detailed Description

Initiation of NIV treatment implies technical adjustments (choice of mask and ventilator), but also patient education by the nurses and medical staff. The settings are generally adjusted during the daytime in awake patients. The appropriateness of these settings is generally not optimal during sleep as many respiratory events (hypopnoea, apnea, leaks, desynchronization, and glottic closure) may occur under NIV then reducing the effectiveness of treatment. These nocturnal abnormalities are routinely evaluated by measuring their consequences, i.e. oxygen desaturation and the level of PaCO2 after wake up. Some teams are now proposing to better characterize what happens when using NIV during sleep using polysomnography (PSG). The precise characterization of residual events under treatment may allow optimizing ventilator settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity-Hypoventilation Syndrome (OHS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

patients will benefit from a complete polysomnography under NIV

Arm Title

Arm Type

Active Comparator

Arm Description

settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas

Intervention Type

Device

Intervention Name(s)

GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

Intervention Description

Primary Outcome Measure Information:

Title

Diurnal PaCO2

Time Frame

June 2008

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient male or female, aged 20 to 75 years Patient with a OHS in stable condition, with a BMI> 32 kg/m2 and a PaCO2> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation Patient affiliated to a social security insurance Having given its written informed consent to participate to the study Exclusion Criteria: Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70% Patients suffering from heart failure with periodic breathing Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities Unbalanced Psychiatric Diseases Patients with a respiratory decompensation the month preceding the study Patients not autonomous in the use of the NIV Pacemaker patients, constituting a contraindication to magnetic stimulation Sensitive subjects, in accordance with article L 1121-6 of the French Public Health Code Patients with long term by steroids or other anti-inflammatory drugs

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maud Boucherie, CRA

maud.boucherie@covidien.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Louis pepin, Pr

Organizational Affiliation

University Hospital, Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble

City

Grenoble

State/Province

Cedex 9

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Louis Pepin, Pr

JLPepin@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Jean-Christian Borel

JCBorel@chu-grenoble.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

21885724

Citation

Borel JC, Tamisier R, Gonzalez-Bermejo J, Baguet JP, Monneret D, Arnol N, Roux-Lombard P, Wuyam B, Levy P, Pepin JL. Noninvasive ventilation in mild obesity hypoventilation syndrome: a randomized controlled trial. Chest. 2012 Mar;141(3):692-702. doi: 10.1378/chest.10-2531. Epub 2011 Sep 1.

Results Reference

derived

PubMed Identifier

19701463

Citation

Borel JC, Roux-Lombard P, Tamisier R, Arnaud C, Monneret D, Arnol N, Baguet JP, Levy P, Pepin JL. Endothelial dysfunction and specific inflammation in obesity hypoventilation syndrome. PLoS One. 2009 Aug 24;4(8):e6733. doi: 10.1371/journal.pone.0006733.

Results Reference

derived

Learn more about this trial

Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization

We'll reach out to this number within 24 hrs