None listed
Conditions
Brief summary
Obstructive sleep apnea (OSA) is a common sleep breathing disorder affecting up to 7% of the adult population and characterized by periodic collapse of the upper airway during sleep. Continuous positive airway pressure (CPAP) is the primary treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway obstruction, compliance with therapy has been sub optimal at best. Pressure relief was developed to improve patient comfort by reducing the pressure when therapeutic pressure is not required. This trial is a randomised and unblinded study comparing a prototype device with a market released device, and will compare the two based on device efficacy and patient comfort. This trial will be conducted as a combination of in-lab (at Fisher & Paykel Healthcare Sleep Laboratory, Auckland) and in-home (where the participant takes the trial device and uses it as their primary therapy for a set duration of the trial).
Interventions
The investigation device is a modified humidified continuous positive airway pressure (CPAP) device (Fisher & Paykel Healthcare ICON). The modification will include a form of pressure relief, to improve patient comfort. This investigation will focus on fixed CPAP only.
The clinical investigation device will be supplying continuous positive airway pressure with humidity and pressure alleviation to the patient via a hose and mask (mouth/nose). The device will be monitoring the flow signal of the
The investigation device is a modified humidified continuous positive airway pressure (CPAP) device (Fisher & Paykel Healthcare ICON). The modification will include a form of pressure relief, to improve patient comfort. This investigation will focus on fixed CPAP only. The clinical investigation device will be supplying continuous positive airway pressure with humidity and pressure alleviation to the patient via a hose and mask (mouth/nose). The device will be monitoring the flow signal of the patient in order to detect apnea, hypopnea and flow limitations. In Auto-PAP mode these events will trigger the device to adjust the pressure in order eliminate sleep disordered breathing events. In fixed-CPAP mode this pressure will be fixed to the pressure that the patient was prescribed by a sleep physician. For the in-lab portion of the trial, the investigation device will be used for half the night before they are switched over to the control treatment for the rest of the night, or vice versa (randomised). Subjects will undergo a full polysomnograpy (PSG) For the in-home portion of the trial, the investigation devices (investigation and control) will be used by the patient at home for a period of 2 weeks, after which they will cross-over to the alternate device. The washout period will serve as the first week on the new device, meaning that only the second week's data (in both arms)will be used for analysis. Adherence to therapy is measure by an in-built hours used counter in the CPAP device (as is normal practice for CPAP therapy). As such, there are no additional strategies required for monitoring adherence in the study.
Sponsors
Hanie Yee
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18+ Diagnosed with OSA by a practicing sleep physician
Exclusion criteria
Patients that have used CPAP with pressure relief in the last two years, to prevent bias towards their current device. Patients with a known history of Cerebrospinal fluid leak, abnormalities of the cribriform plate, head trauma and/or pneumocephalus Patients with pathologically low blood pressure, pneumothorax, a previous history of pneumothorax, or for patients who have an increased risk of pneumothorax, such as those with bullous lung disease Patient with bypassed upper airway Patients with COPD or respiratory failure Patients that require supplemental oxygen with their CPAP device Patients with implanted electronic medical devices (e.g. cardiac pacemakers), to prevent interfernce with/by trial machine
Outcome results
None listed