RecruitingACTRN12618000379213

Comparing auto-titrating continuous positive airway pressure device with fixed continuous positive airway pressure device in improvement in hypercapnia among patients with obesity hypoventilation syndrome

Assessing the Efficacy of Auto-titrating versus Fixed Continuous Positive Airway Pressure in Obesity Hypoventilation Syndrome

Sponsor

Yizhong Zheng

Enrollment

40 participants

Start Date

Aug 20, 2018

Study Type

Interventional

Conditions

Sleep Apnoea

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is for people with obesity hypoventilation syndrome — a condition where excess weight causes breathing to become shallow, especially during sleep, leading to a dangerous build-up of carbon dioxide in the blood. Many of these patients also have severe sleep apnoea. The standard treatment is a CPAP machine (a mask worn during sleep that delivers pressurised air to keep the airway open), but there are two types: one with a fixed pressure and one that automatically adjusts pressure throughout the night. This study compares the auto-adjusting CPAP to standard fixed-pressure CPAP to see whether one is better at reducing carbon dioxide levels, improving sleep quality, and supporting cardiovascular health. Researchers believe the auto-adjusting device may work just as well and be easier to tolerate. You may be eligible if you have a BMI over 30, have been told your blood carbon dioxide is too high during the day, have not used CPAP in the past year, and have severe sleep apnoea. People with other causes of breathing problems (such as lung disease or muscle weakness), heart failure, or those who are not fluent in English are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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.

Locations(1)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

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