Investigation of a novel obstructive sleep apnea therapeutic method

The clinical trials was supervised by the principle investigator. The data was collected by the Co investigator and the sponsor team. This trial involved overnight sleep studies, two non consecutive nights, run between the hours of 8pm to 8am for four to eight hours, depending on the duration of the participants sleep. During the first sleep study, the participants used usual CPAP therapy at lower than normal pressure (70% of the participant's usual pressure), and the second, was as per the first trial, but with the improved CPAP setup using pressure oscillations . The added pressure oscillations was 1 cmH2O. The apparatus used to do this trial will comprise a CPAP device as per the above set at 70% of your usual pressure with a pressure oscillator connected to the usual CPAP. Both techniques used without humidification. The pressure oscillations were the same for all participants. A minimum break period was included between each trial, at least 24 hours between trials. sleep lab attendance checklists were considered and each participant has a case report form that all the resulted data were reported in to compare the two therapies results for each participant. The participant was sleep in sleep labs with a comfortable bed. and they asked to wear your usual CPAP full face mask and to lie down, relax and go to sleep as they usually would. Sensors is attached to their head and body to collect data about their sleep and CPAP therapy. sleep data is saved, and then they have been asked to come back at an agreed time for the second sleep study of the same duration. no follow-ups appointments after this trials. During nights, they've been monitored by a noninvasive device called Polysomnography or PSG. The Polysomnography device model type that will be used in the trials is the Embla S4500, used to collect their physiological data during sleep, as well as identifying sleep arousals. The Polysomnography collects data via multiple electrodes/sensors to their head and body. The head electrodes record the following physiological parameters: • Brain activity: Electroencephalograph (EEG). • Chin muscle activity: Electromyography (EMG). • Eye muscle movement: Electrooculography (EOG). • Snoring recorder. The body electrodes recorded the following physiological parameters: • Heart rhythm via Electrocardiograph ECG. • Oxygen level in the blood, by placing a sensor on the indicator fingertip. • Breathing effort by wearing two belts, one on the chest and the other on the abdomen. • Skeletal muscle activity (EMG). Where the electrodes are attached to the legs. A function generator was connected to control the pressure oscillations, and the Polysomnography was used to gauge the status of the sleep. All sleeping parameters was recorded via the Polysomnography. Saliva samples was taken before and after each trial to make a comparison in the mouth dryness when using CPAP and superimposed pressure oscillations with CPAP. This is conducted by comparing the quantity or the volume of saliva. For the saliva collection, they instructed to rinse your mouth thoroughly with deionized water prior to collection. Then seated upright and relaxed accumulate saliva in the floor of the mouth and to then spit into a cylinder. This will take 5 minutes, once completed, samples are then discarded. When the trials and tests are completed, their code information data is held in the Auckland University of Technology (AUT), Institute of Biomedical Technologies (IBTec). It is a controlled-access database, which means that the information in this database is available only to researchers of IBTec. The results analyzed to get the conclusion of the study.