NCT01405313

Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional ASV.

Detailed description

Adaptive servoventilation (ASV) is a type of non-invasive ventilation which ameliorates central sleep and/or mixed apnea and periodic breathing. Previous studies in the field have shown that treatment of periodic breathing with ASV improves sleep quality and quality of life. In reducing central apneas, ASV reduces overall arousal index, and increases overall slow wave sleep and rapid eye movement (REM) sleep more than oxygen, continuous positive airway pressure or bi-level treatments. ASV can also more effectively reduce central apnea and overall apnea/hypopnea index (AHI) in patients on long-term opiates, and appears to effectively treat Complex Sleep Apnea Syndrome. It is more effective than other forms of non-invasive ventilation for patients with central and/or mixed apnea or periodic breathing, and is better tolerated. This is a prospective, randomised, crossover, observational study. Subjects will spend one night on conventional ASV and one night on modified ASV with full in-lab polysomnography (PSG) during therapy on both nights. Objective and subjective parameters will be recorded and analysed.

Conditions

• Periodic Breathing
• Breathing-Related Sleep Disorder

Interventions

Type	Name	Description
DEVICE	Modified Adaptive Servoventilation Device	The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.
DEVICE	Conventional Adaptive Servoventilation device	Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-07-29
• Last updated: 2017-03-20
• Results posted: 2017-03-20

Locations

1 site across 1 country: Germany