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Completed

NCT Number: NCT01757444

Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS

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.

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Key information

Conditions

Obesity Hypoventilation Syndrome Apnea Dyssomnias Hypoventilation Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire d'Angers, Angers, France

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About this study

Efficacy on sleep quality, symptoms, physical activity and quality of life

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Chronic obstructive pulmonary disease
  • Neuromuscular disease
  • Scoliosis
  • Cardiac insufficiency
  • Significant psychiatric disease
  • Sleep apnea syndrome with central apnea index > 10%
  • Treatment with benzodiazepines at the inclusion

Treatment and study plan

BiPAP - A40

Device

Patients receiving BiPAP AVAPS - AE ventilatory mode at home

BiPAP - ST

Device

Patients receiving BiPAP- ST mode at home.

Primary outcomes

  1. CHANGE IN SLEEP QUALITY

    Time frame: Day 1 and Day 61

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

Secondary outcomes

  1. CHANGE IN GAZ EXCHANGE

    Time frame: Day 1 and Day 61

Other outcomes

  1. CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION

    Time frame: Day 1 and Day 61

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 31, 2012
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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