None listed
Conditions
Brief summary
The aim of our study is to examine the efficacy and safety of auto-titrating continuous positive airway pressure devices (CPAP) when compared to standard of care fixed-pressure CPAP in patients with obesity hypoventilation syndrome with concurrent severe obstructive sleep apnoea who are suitable for CPAP therapy. We hypothesis that auto-titrating CPAP is not inferior to CPAP with respect to improvements in ventilatory failure (measured by arterial CO2 tension), sleep quality, quality of life as well as a number of cardiovascular biomarkers.
Interventions
Exposure Group: Auto-titrating CPAP device (Phillips Dreamstation/Resmed Airsense 10), this uses an algorithm to adjust the delivered positive airway pressure according to the detected airflow obstruction during sleep.
CPAP therapy will be delivered using a nasal or full face mask interface. All subjects will have mask fitting performed by sleep technicians to ensure optimal interface is used for the duration of the study.
All subjects will receive mask and CPAP device education from sleep t
Exposure Group: Auto-titrating CPAP device (Phillips Dreamstation/Resmed Airsense 10), this uses an algorithm to adjust the delivered positive airway pressure according to the detected airflow obstruction during sleep. CPAP therapy will be delivered using a nasal or full face mask interface. All subjects will have mask fitting performed by sleep technicians to ensure optimal interface is used for the duration of the study. All subjects will receive mask and CPAP device education from sleep technicians as per usual clinical care. The sleep technicians are employed by Royal Prince Alfred Respiratory and Sleep Medicine unit with appropriate accreditation. Subjects will receive clinical support from sleep physicians during individual clinical reviews as per usual care of patients with obesity hypoventilation syndrome. Subjects will be provided their allocated therapy to be used during sleep every night, in the participant's home, for a period of 3 months for assessment of primary outcome. The delivered pressure will be at an autoset range of 8-20cmH2O. They will have an overnight sleep study on their loaned auto-titrating CPAP device. This pressure range is expected to resolve most airway obstruction events encountered in our study subjects. CPAP adherence will assessed. The data is recorded in a data chip in each CPAP device. This data will be downloaded by sleep technicians at the end of study (3months) for assessment of CPAP compliance. This is usual standard of care.
Sponsors
Yizhong Zheng
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• BMI>30kg.m-2 • Daytime respiratory failure with a PaCO2>45mmHg (OHS group) • pH is in the normal range at admission (7.35-7.45) • Treatment naïve of long-term positive airway pressure device i.e. the patient has not been using CPAP in the past 12 months. • AHI>/= 30 events per hour
Exclusion criteria
• Presence of any other condition that may contribute to hypoventilation including neuromuscular disease, chest wall abnormalities, respiratory depressant medications, COPD or an FEV1/FVC ratio of <0.7 • Uncontrolled medical or psychiatric conditions • Any pre-existing heart failure with reduced ejection fraction • Any pre-existing CVA/TIA • Decompensated right heart failure • Not proficient in English • Inability to provide informed consent • PaCO2 >60mmHg
Outcome results
None listed