Optimal Therapy for Obesity Hypoventilation Syndrome

Completed

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

• Registration Number: ACTRN12611000874910
• Lead Sponsor: Institute for Breathing and Sleep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Primary diagnosis of Obesity Hypoventilation Syndrome
Body mass index >30kg.m-2
Daytime respiratory failure with a PaCO2>45mmHg
At randomization, pH is in the normal range for chronic hypercapnia
FEV1/FVC ratio >70%

Exclusion Criteria

Hypoventilation attributable to other causes eg neuromuscular disease, chest wall abnormalities, multiple medications with sedative/respiratory depressant side-effects
Physician diagnosed chronic obstructive pulmonary disease
Has used non-invasive ventilation (Bilevel PAP or CPAP) for more than one month in the previous 3 months.
Not proficient in English
Inability to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment failure defined as any one or more of the following;<br>a)Failure of awake PaCO2 to fall below 60mmHg within 3 months of commencing treatment or a rise of >10mmHg in daytime, awake PaCO2 at any time compare to that at randomization<br>b)Admission to hospital for respiratory deterioration (worsening respiratory failure, dyspnoea, right heart failure or severe sleepiness)<br>c)The patient abandons or is non-adherent with PAP therapy, defined as average nightly use <2hrs/night since last review, on 2 consecutive reviews (ie persisting after efforts to trouble shoot reasons for poor adherence).[Three and 12 months]