NCT00603096

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 28, 2008

Status Verified

January 1, 2008

Enrollment Period

2 years

First QC Date

January 15, 2008

Last Update Submit

January 15, 2008

Conditions

Obesity-Hypoventilation Syndrome (OHS)

Outcome Measures

Primary Outcomes (1)

  • Diurnal PaCO2

    June 2008

Study Arms (2)

1

EXPERIMENTAL

patients will benefit from a complete polysomnography under NIV

Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

2

ACTIVE COMPARATOR

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

Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

Interventions

GoodKnight 425ST - Mallinckrodt DF, Tyco HealthcareDEVICE

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.

12

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble

Grenoble, Cedex 9, 38043, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 21885724DERIVED

  • 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.

    PMID: 19701463DERIVED

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Jean-Louis pepin, Pr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maud Boucherie, CRA

CONTACT

maud.boucherie@covidien.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

June 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 28, 2008

Record last verified: 2008-01

Locations

FR(1)