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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000778684

Enrollment

Registered

2005-12-07

Start date

2007-05-01

Completion date

2011-06-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results