Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Market released PAP device | Active Comparator | Use of a market released PAP device |
|
| Modified PAP device | Experimental | Us of the modified PAP device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAP device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 1 night in the sleep lab and 3 weeks use of the device in the home. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 1 night in the sleep lab and 3 weeks use of the device in the home. |
| PAP Compliance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hanie Yee | Fisher & Paykel Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare | Auckland | 2013 | New Zealand |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Modified PAP Device First, Then Market Released PAP Device | Use 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Events per hour | After 1 night in the sleep lab and 3 weeks use of the device in the home. |
|
6 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified PAP Device | Use of a modified PAP device for 3 more weeks. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Snoring and somnolence | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher & Paykel Healthcare | +6495740123 | cpaptrial@fphcare.co.nz |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger. |
| After 1 night in the sleep lab and 3 weeks use of the device in the home. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Modified PAP Device |
Use of the modified PAP device PAP device |
|
|
| 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. | 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. | Posted | Median | Full Range | Units on a Scale | After 1 night in the sleep lab and 3 weeks use of the device in the home. |
|
|
|
| Secondary | PAP Compliance | Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger. | 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. | Posted | Mean | Standard Deviation | Minutes | After 1 night in the sleep lab and 3 weeks use of the device in the home. |
|
|
|
| 49 |
| 0 |
| 49 |
| 5 |
| 49 |
| EG001 | Market Released PAP Device | Use of a market released PAP device for 3 more weeks. | 0 | 43 | 0 | 43 | 3 | 43 |
| Nose bleed | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Angioedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Determined by hospital physicians to be related to patients Blood Pressure medications |
|
| High AHI on PSG | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shoulder Operation | Surgical and medical procedures | Systematic Assessment |
|
| Ectopic Beats | Cardiac disorders | Systematic Assessment | Observed during PSG |
|
| Cricopharyngeal Spasm | Skin and subcutaneous tissue disorders | Systematic Assessment | Sensation of lump in the throat |
|
Not provided
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |