NCT01748656

Brief Summary

Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 14, 2014

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

December 11, 2012

Last Update Submit

March 13, 2014

Conditions

Obesity Hypoventilation Syndrome

Keywords

Noninvasive ventilationObesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (1)

  • Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)

    transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.

    1 night

Secondary Outcomes (6)

  • Mean transcutaneous CO2 pressure during REM Sleep

    1 Night

  • Mean nocturnal SpO2

    1 night

  • Awake arterial PaCO2 after 1 hour of NIPPV withdrawal

    After 1 night

  • Micro-arousals/hour of sleep

    1 night

  • Sleep Quality assess by Visual analogic scale (100mm)

    1 night

  • +1 more secondary outcomes

Study Arms (2)

AVAPS

ACTIVE COMPARATOR

AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night

Device: IVAPS

IVAPS

ACTIVE COMPARATOR

IVAPS mode(STELAR 150-RESMED)1 night

Device: AVAPS

Interventions

IVAPSDEVICE

IVAPS mode (RESMED Stelar 150) during 1 night

AVAPS
AVAPSDEVICE

AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night

IVAPS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years old
  • In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).

You may not qualify if:

  • patient treated with additional long term Oxygen therapy
  • Patient previously treated by AVAPS mode or IVAPS mode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Laboratory, Grenoble Univeristy Hospital

Grenoble, 38900, France

Location

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, MD PHD

    CHU Grenoble France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 12, 2012

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

February 1, 2014

Last Updated

March 14, 2014

Record last verified: 2012-12

Locations

FR(1)