NCT01757444

Brief Summary

In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 17, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

5.3 years

First QC Date

December 17, 2012

Last Update Submit

September 10, 2018

Conditions

Obesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (1)

  • CHANGE IN SLEEP QUALITY

    Sleep stage, micro arousals, apnea/hypopnea index...

    Day 1 and Day 61

Secondary Outcomes (1)

  • CHANGE IN GAZ EXCHANGE

    Day 1 and Day 61

Other Outcomes (1)

  • CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION

    Day 1 and Day 61

Study Arms (2)

BiPAP - A40

EXPERIMENTAL

BiPAP with AVAPS AE mode

Device: BiPAP - A40

BiPAP- ST

ACTIVE COMPARATOR

Patients receiving BiPAP- ST at home

Device: BiPAP - ST

Interventions

BiPAP - A40DEVICE

Patients receiving BiPAP AVAPS - AE ventilatory mode at home

BiPAP - A40
BiPAP - STDEVICE

Patients receiving BiPAP- ST mode at home.

BiPAP- ST

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman, stable patient with obesity hypoventilation syndrome, naives of non invasive ventilation.
  • PaCO2 ≥ 45 mmHg.
  • PaO2 \< 70 mmHg
  • BMI ≥ 30Kg. m2

You may not qualify if:

  • Chronic obstructive pulmonary disease
  • Neuromuscular disease
  • Scoliosis
  • Cardiac insufficiency
  • Significant psychiatric disease
  • Sleep apnea syndrome with central apnea index \> 10%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Centre Hospitalier Universitaire d'Angers

Angers, France

Location

Centre Hospitalier de Béziers

Béziers, France

Location

Hôpital Haut- Lévêque

Bordeaux, France

Location

Centre Hospitalier de Cannes

Cannes, France

Location

Clinique du Parc

Castelnau-le-Lez, France

Location

Hôpital du Bocage

Dijon, France

Location

Hôpital Michallon

Grenoble, France

Location

Hôpital Pitié-Salpêtrière

Paris, France

Location

Hôpital La Milétrie

Poitiers, France

Location

Hôpital de Bois Guillaume

Rouen, France

Location

Hôpital Larrey

Toulouse, 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-François MUIR, Pr

    Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 31, 2012

Study Start

June 1, 2013

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

FR(11)