Obstructive Sleep Apnea (OSA)
Conditions
Brief summary
This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance. Patients will have their treatment pressure titrated using polysomnography (PSG) in the sleep laboratory, and then in a random order will spend additional time undergoing PSG using both devices, and using both devices at home for 3 weeks. Data will be collected from the PSG studies, device downloads, independent pressure-flow loggers, and custom questionnaires.
Detailed description
The study will be held in two parts. The main portion of the study which compares the modified PAP device and the market released product including the laboratory testing and home testing of the devices will be called 'Part A'. Additional nights using the PAP device with PSG monitoring will be used to gather additional observational flow data to allow distortion testing and investigation of the FPH (Fisher & Paykel Healthcare) SensAwake (an unique feature which automatically lowers the pressure when a patient wakes up) algorithm while using PAP, this is part B. Part A After the patient has undergone informed consent, their demographic and clinical variables will be collected and entered into a case report form (CRF) before any setup procedure is started. The patient will be asked to complete questionnaires regarding their normal therapy (ESS (Epworth Sleepiness Score), FOSQ (Functional Outcomes of Sleep Questionnaire), custom therapy comfort questionnaire), and then will be set up for a standard PSG. The patient will use their prescribed mask and a clean water chamber and breathing tube which will be connected to the modified PAP device. The patients will sleep on the device throughout the night while having their PAP titrated by a qualified sleep technician. Pressure titration is necessary for two reasons: firstly, it may have been a period of time since the participants last titration, and secondly this version of PAP involves the use of different levels of pressure. Pressures will be titrated according to the AASM (American Academy of Sleep Medicine) Clinical Guidelines for the Manual Titration of Positive Airway Pressure in Patients with OSA. The participant will be randomized to either the modified PAP or market released device group. They will be issued with a PAP device and a pressure-flow logger to be used at home in the usual manner of their PAP therapy for 3 weeks (+/- 4 days), after which participants will return to the FPH sleep laboratory to participate in a overnight PSG study using their first device. At this visit the participant will also swap to the second PAP device; and the above home use repeated on device 2. Part B After informed consent form the patient will be set up for a standard PSG, and sleep overnight using the modified PAP device, their prescribed mask, and a clean water chamber and breathing tube. This testing will be performed to provide additional flow data to the development engineers. This includes, but is not limited to, distortion testing and adjustment of device parameters during the sleep study. Distortion testing analyses the impact of the PAP pressure changes on the participants breathing or airflow.
Interventions
DEVICEPAP device
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18+ * Diagnosed with OSA by a practicing sleep physician
Exclusion criteria
* 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 dehydration. * Patient with bypassed upper airway * Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea) * Previous use of a bi-level device with-in the last 2 years (from enrolment date). * Patients with respiratory failure, bullous lung disease or COPD (Chronic Obstructive Pulmonary Disease). * Patients with obesity hypoventilation syndrome or congestive heart failure * Patients that require supplemental oxygen with their CPAP (Continuous Positive Airway Pressure) device * Patients with implanted or life-supporting electronic medical devices (e.g. cardiac pacemakers)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAP Treatment Efficacy | After 1 night in the sleep lab and 3 weeks use of the device in the home. | The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PAP Treatment Comfort | After 1 night in the sleep lab and 3 weeks use of the device in the home. | Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable. |
| PAP Compliance | After 1 night in the sleep lab and 3 weeks use of the device in the home. | Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger. |
Countries
New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Market Released PAP Device First, Then Modified PAP Device Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study. | 26 |
| Modified PAP Device First, Then Market Released PAP Device Us of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study. | 23 |
| Total | 49 |
Baseline characteristics
| Characteristic | Market Released PAP Device First, Then Modified PAP Device | Modified PAP Device First, Then Market Released PAP Device | Total |
|---|---|---|---|
| Age, Continuous | 63.2 years | 58.7 years | 60.9 years |
| Region of Enrollment New Zealand | 26 participants | 23 participants | 49 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 24 Participants | 22 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 43 |
| other Total, other adverse events | 5 / 49 | 3 / 43 |
| serious Total, serious adverse events | 0 / 49 | 0 / 43 |
Outcome results
Primary
PAP Treatment Efficacy
The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.
Time frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
Population: The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 37 had usable data for analysis after using each device. AHI was compared between devices independent of which order the participants used each device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Market Released PAP Device | PAP Treatment Efficacy | 4.2 Events per hour | Standard Deviation 1 |
| Modified PAP Device | PAP Treatment Efficacy | 4.0 Events per hour | Standard Deviation 1 |
Secondary
PAP Compliance
Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.
Time frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
Population: The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 31 had usable data for analysis after using both devices. Compliance was compared between devices independent of which order the participants used each device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Market Released PAP Device | PAP Compliance | 438 Minutes | Standard Deviation 13 |
| Modified PAP Device | PAP Compliance | 430 Minutes | Standard Deviation 12 |
Secondary
PAP Treatment Comfort
Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.
Time frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
Population: The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 35 had usable data for analysis after using each device. PAP treatment comfort was compared between devices independent of which order the participants used each device.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Market Released PAP Device | PAP Treatment Comfort | 5 Units on a Scale |
| Modified PAP Device | PAP Treatment Comfort | 5 Units on a Scale |