The treatment of stable obesity hypoventilation syndrome (OHS)

Phase 3

Completed

• Conditions: Obesity hypoventilation syndrome; Diet and Nutrition - Obesity; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12605000778684
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arousals from sleep per hour[Raw Polysomnographic (sleep study) data are collected during each overnight sleep study and summary indices are generated later.];Rate of desaturation[Raw Polysomnographic (sleep study) data are collected during each overnight sleep study and summary indices are generated later.]

Secondary Outcome Measures

Name	Time	Method
Sleepiness[Assessed each morning.];Machine preference[At study conclusion.]