Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization - Full Text View

Sponsor:	Tyco Healthcare Group
Information provided by:	Tyco Healthcare Group
ClinicalTrials.gov Identifier:	NCT00603096

Purpose

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.

Condition	Intervention
Obesity-Hypoventilation Syndrome (OHS)	Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Tyco Healthcare Group:

Primary Outcome Measures:

Diurnal PaCO2 [ Time Frame: June 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental patients will benefit from a complete polysomnography under NIV	Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare 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.
2: Active Comparator settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas	Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare 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.

Arms

Assigned Interventions

1: Experimental

patients will benefit from a complete polysomnography under NIV

Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

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.

2: Active Comparator

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

Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603096

Contacts

Contact: Maud Boucherie, CRA

maud.boucherie@covidien.com

Locations

France, Cedex 9
Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble	Recruiting
Grenoble, Cedex 9, France, 38043
Contact: Jean-Louis Pepin, Pr JLPepin@chu-grenoble.fr
Contact: Jean-Christian Borel JCBorel@chu-grenoble.fr

Sponsors and Collaborators

Tyco Healthcare Group

Investigators

Principal Investigator:

Jean-Louis pepin, Pr

CHU Grenoble

More Information

No publications provided by Tyco Healthcare Group

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	tyco Healthcare Group ( EMEA Clinical Affairs Director )
Study ID Numbers:	38/2006/2, Ethics Comittee ref.06-TYCO-1
Study First Received:	January 15, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00603096 History of Changes
Health Authority:	France: Institutional Ethical Committee

Additional relevant MeSH terms:

Obesity
Sleep Apnea Syndromes
Disease
Apnea
Nervous System Diseases
Obesity Hypoventilation Syndrome
Sleep Apnea, Obstructive
Respiration Disorders
Hypoventilation
Sleep Disorders
Dyssomnias

Overweight
Sleep Disorders, Intrinsic
Body Weight
Signs and Symptoms
Pathologic Processes
Respiratory Insufficiency
Respiratory Tract Diseases
Syndrome
Signs and Symptoms, Respiratory
Nutrition Disorders
Overnutrition

ClinicalTrials.gov processed this record on November 25, 2009