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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Tyco Healthcare Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tyco Healthcare Group
ClinicalTrials.gov Identifier:
NCT00603096
First received: January 15, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)

Resource links provided by NLM:


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
Experimental: 1
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.
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Maud Boucherie, CRA maud.boucherie@covidien.com

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

Additional relevant MeSH terms:
Obesity
Hypoventilation
Respiratory Insufficiency
Syndrome
Obesity Hypoventilation Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Disease
Pathologic Processes
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014