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Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and pressure data, and complete questionnaires regarding satisfaction and ease of use at the end of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard masks for CPAP therapy in terms of ease of use, satisfaction and overall titration experience.
Participants will be recruited from patients who visit the sleep lab for CPAP titration. Only eligible participants, that provide written informed consent, will be enrolled into the investigation
Only those participants whom are previously diagnosed with an AHI >5 can be approached and enrolled into the study.
Once the consent form has been signed, participants will be randomly assigned to receive either Pilairo or any other standard care nasal/nasal pillows mask for their CPAP titration. A randomisation log will be provided by FPH.
The titration session will take place as per the lab's routine practice.
Throughout the night the Sleep Technician will record in the CRF the absolute leak value for the mask every 10 minutes.
At the end of the session the Sleep Technician will complete a questionnaire in relation to the titration experience for that participant/mask. The data will be collected in the CRF that FPH staff will provide to the site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FPH Pilairo Q CPAP mask | Experimental | The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant. |
|
| Any other market released nasal or nasal-pillow CPAP mask | Active Comparator | The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FPH Pilairo Q CPAP mask | Device | CPAP nasal-pillow mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Questionnaire of Mask Experience | Sleep technicians reported on their experience using the mask after 1 night in the lab on a scale from 1 to 10 with a higher score indicating a better experience | 1 night in the lab |
| Measure | Description | Time Frame |
|---|---|---|
| Mask Leak | The Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study. | Every 10min, for up to 8 hours |
| Sleep Technicians Recommendation to Use Mask |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martina Neddermann, Dr.med | Evangelisches Krankenhaus Herne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelisches Krankenhaus Herne | Herne | 44651 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | FPH Pilairo Q CPAP Mask | The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant. FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask |
| FG001 | Any Other Market Released Nasal or Nasal-pillow CPAP Mask | The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FPH Pilairo Q CPAP Mask | The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant. FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask |
| BG001 | Any Other Market Released Nasal or Nasal-pillow CPAP Mask |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age information was only collected at the 18+ level. No other age information was collected. |
| 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 | Subjective Questionnaire of Mask Experience | Sleep technicians reported on their experience using the mask after 1 night in the lab on a scale from 1 to 10 with a higher score indicating a better experience | While not all participants completed the full study, participants who provided acceptable data were used in the analysis. The number of participants analyzed may be different from the number who completed. Due to the nature of this study, participant completion did not have a direct effect on this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | 1 night in the lab |
|
1 night 1 Night in Lab. Adverse event data was collected for the full time each participant remained in the trial, from informed consent until study completion or withdrawal. Each participant spent a different amount of time in the lab enrolled in the trial due to their sleep behavior. Therefore, a specific amount of time (or average) is not appropriate.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FPH Pilairo Q CPAP Mask | The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant. FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher and Paykel Healthcare | +64 09 574 0123 | CPAPtrial@fphcare.co.nz |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Any other market released nasal or nasal-pillow CPAP mask | Device | Any other market released nasal or nasal-pillow CPAP mask |
|
Sleep Technicians reported on whether they would recommend the mask to other professionals. Ratings were out of 1-10 and a higher score indicates a higher likelihood of recommending the mask.
| 1 night in the lab |
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Any Other Market Released Nasal or Nasal-pillow CPAP Mask |
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask |
|
|
| Secondary | Mask Leak | The Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study. | Posted | Mean | Standard Error | liters/minute | Every 10min, for up to 8 hours |
|
|
|
| Secondary | Sleep Technicians Recommendation to Use Mask | Sleep Technicians reported on whether they would recommend the mask to other professionals. Ratings were out of 1-10 and a higher score indicates a higher likelihood of recommending the mask. | Posted | Mean | Standard Deviation | units on a scale | 1 night in the lab |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | Any Other Market Released Nasal or Nasal-pillow CPAP Mask | The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask | 0 | 25 | 0 | 25 | 0 | 25 |
| Low SpO2 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |