CompletedPhase 3Phase 4ACTRN12605000778684

The treatment of stable obesity hypoventilation syndrome (OHS)

A randomised controlled trial of the effects of one night of CPAP (Continuous Positive Airway Pressure), Bilevel(s, spontaneous mode) or Bilevel(c, controlled mode) therapy on sleep and oxygenation in the Obesity Hypoventilation Syndrome (OHS)


Sponsor

Austin Health

Enrollment

10 participants

Start Date

May 1, 2007

Study Type

Interventional

Conditions

Summary

The study will address two important questions. We anticipate that the results of this study will assist us with the clinical management of Victorian Respiratory Support Service patients with Obesity Hypoventilation Syndrome. In addition, we are leading the planning of a multi-centre RCT of non-invasive ventilation treatment in Obesity Hypoventilation Syndrome. Data from the current project will assist with the design of that application (for submission next year to the NHMRC) in terms of sample size estimations, feasibility and the provision of pilot data.


Eligibility

Sex: Both males and females

Inclusion Criteria1

  • Clinically stable people with OHS. Stability defined as > 3 months on current therapy (either CPAP, Bilevel(s) or Bilevel(c).Obesity (Body Mass Index > 30 kg/m2)Hypoventilation; Daytime hypercapnia (PaCO2 > 45 mmHg) with or without acidosis prior to initiation of treatment for OHS.

Exclusion Criteria1

  • Physician diagnosed Chronic Obstructive Pulmonary Disease (COPD)Respiratory failure attributable to other causes, eg neuromuscular disease. An inability to provide informed consent.

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Interventions

The effects of one night of CPAP, Bilevel (s) and Bilevel (c) for OHS. Each subject will be studied on all 3 therpay modes (crossover trial, with 2 week washout period in between)

The effects of one night of CPAP, Bilevel (s) and Bilevel (c) for OHS. Each subject will be studied on all 3 therpay modes (crossover trial, with 2 week washout period in between)


Locations(1)

VIC, Australia

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ACTRN12605000778684