The impact of controllable pressure oscillation Continuous positive airway pressure device in obstructive sleep apnea patients

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2014
INTERVENTION: Pressure oscillation (PO) superimposed to a standard continous positive airway pressure (CPAP) for the treatment of sleep apnoea. a) Continuous positive airway pressure (CPAP) is the standard treatment for obsructive sleep apnea. CPAP is a pressure applied through a mask by a constant flow that allows to open the upperairway during sleep. In this study we will test if small fluctuations in air pressure superimposed to a standard CPAP allows a better control of apneas during sleep. Thus, participants will undergo polysomnography for 2 consecutive nights. b) Patients will sleep one night in the sleep laboratory with their standard CPAP and one night with the new device, incorporating a superimposed pressure oscillation to the CPAP, in a random order. A polysomnography will be performed during the studied nights to monitor sleep and respiratory parameters. Participants will undergo polysomnography for 2 consecutive nights c) During the CPAP night patients will receve their habitual pressure. During the PO‐CPAP night they will receive their habitual CPAP pressure +/‐ 1 cmH2O d) The duration of the study will be 2 nights: participants will be using standard CPAP for one night and PO‐CPAP in one night. e) Patients will be monitored and assisted during the entire night by a specialized polysomnography technician CONDITION: sleep apnoea PRIMARY OUTCOME: Apnoea/hypopnea index (number of apnoeas/hypopneas per hour of sleep) assesed by complete polysomnography (in‐lab) SECONDARY OUTCOME: Oxygen desaturation index assesed with nocturnal oxymetry during polysomnography INCLUSION CRITERIA: Patients with sleep apnoea syndrome currently treated with standard CPAP
Epistemonikos ID: e99bf6c40c895d512e89a393f5a39b92cdc2e7ea
First added on: Aug 25, 2024