None listed
Conditions
Brief summary
Obstructive Sleep Apnea (OSA) is the most common form of Apnea. Obstructive Sleep Apnea occurs when there are repeated episodes of complete or partial blockage of the upper airway during sleep. During a sleep apnea episode, the diaphragm and chest muscles work harder to open the obstructed airway and pull air into the lungs. Breathing usually resumes with a loud gasp or snort. These episodes can interfere with sound sleep. Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for most people with OSA. With CPAP, a patient wears a mask over their nose and/or mouth. An air blower provides airflow through the nose and/or mouth. The air pressure is adjusted so that it is just enough to prevent the upper airway tissues from collapsing during sleep. In this investigation, we want to further develop and optimize the algorithms used in the Fisher & Paykel Healthcare CPAP machines to improve sleep apnea event detection and patient comfort. The algorithms stored in the device detect sleep disordered breathing events and adjust the therapeutic pressure for elimination of the sleep disordered breathing events and improved patient comfort.
Interventions
The interventions used in this clinical trial will be in the form of changes and optimizations to the software algorithms used by the CPAP medical device used to treat Obstructive Sleep Apnea (OSA). This software drives the therapeutic pressure that is delivered to the patient.
The algorithms modified or optimized are responsible for:
Sleep disordered breathing event detection, which anlayzes a patient's breathing flow and adjusts the pressure accordingly to treat for any apnea events that may
The interventions used in this clinical trial will be in the form of changes and optimizations to the software algorithms used by the CPAP medical device used to treat Obstructive Sleep Apnea (OSA). This software drives the therapeutic pressure that is delivered to the patient. The algorithms modified or optimized are responsible for: Sleep disordered breathing event detection, which anlayzes a patient's breathing flow and adjusts the pressure accordingly to treat for any apnea events that may ariise. Better pressure relief/comfort algorithms, which modify the pressure when it detects a pattern of breathing flow and adjusts the pressure accordingly for the comfort of the patient. Changes to the algorithm will be made by the investigators after analyzing the results of the previous configuration of the algorithm. For the in-lab trial, patients are invited to participate multiple times for the duration of the trial, therefore the algorithm used on the night of their in-lab trial may not be the same every time. The algorithm will be active for the whole duration of the trial, this applies to the in-home and in-lab arms of the investigation. If the patient feels uncomfortable with the trial device, they will always have the option to switch back to their usual prescribed device. The participants will be invited to take part in either or both the in-lab and in-home arms of the trial, with the in-lab trials taking place first for a particular algorithm technology/modification. For the in-lab arm of the trial, the patient will undergo a full night polysomnography (PSG) while using the device. Each patient can take part in the in-lab arm of the trial for up to 5 times for a single algorithm technology/modification with at least a 6 night break between each night session. For the in-home arm of the trial, the patient will take the medical device (F&P Icon) and use the device in a typical home usage scenario instead of their usual CPAP machine. The patients are advised to switch back to their usual device at any time if they feel that the therapy is suboptimal. Each patient can take part in multiple in-home trials over the course of this investigation (only one at a time) and can be on the trial medical device for a maximum of 6 months. The CPAP device used in this trial will be a Fisher & Paykel ICON AUTO machine. This machine is a market released CPAP device and will be the same as a market released device in terms of hardware specifications, with only the algorithm being modified. The CPAP device will be administered via the patient's usual CPAP device mask, different mask variants include full face, nasal, nasal pillow, or oral mask. The CPAP device will provide the same efficacy level in terms of the treatment of OSA symptoms as any other released CPAP device on the market. It will also include the same market-released components and accessories. Patient adherence and usage data will be downloaded from the trial device machine for both the in-lab and in-home parts of the trials. This data will be analyzed by us for any anomalies or irregularities in terms of adherence and physiological parameters. Any unusual readings or results obtained for a patient without history for a particular condition, the patient's general practitioner will be advised about this.
Sponsors
Hanie Yee
Study design
Allocation
Non-randomised trial
Intervention model
Single group
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 and over. Diagnosed with Obstructive Sleep Apnea Healthy Volunteers may also be recruited
Exclusion criteria
Patients that are contraindicated for CPAP or AutoCPAP therapy. Any known factor of disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non-compliance to medical regimens, or unwillingness to comply with study requirement(s). Other significant sleep disorder(s). Patients with obesity hypo-ventilation syndrome or congestive heart failure.
Outcome results
None listed