Obstructive Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFPH Pilairo Q CPAP mask
CPAP nasal-pillow mask
DEVICEAny other market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AHI equal or greater than 15 from the diagnostic night. * Equal or greater than 18 years of age
Exclusion criteria
* Inability to give informed consent. * History of intolerance to CPAP. * Anatomical or physiological conditions making CPAP therapy appropriate (for example a deviated septum)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Questionnaire of Mask Experience | 1 night in the lab | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mask Leak | Every 10min, for up to 8 hours | The Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study. |
| Sleep Technicians Recommendation to Use Mask | 1 night in the lab | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Any Other Market Released Nasal or Nasal-pillow CPAP Mask | Total | FPH Pilairo Q CPAP Mask |
|---|---|---|---|
| Age, Customized Age : 18 + years | 25 participants | 50 participants | 25 participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 19 Participants | 40 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 2 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: 1 night in the lab
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPH Pilairo Q CPAP Mask | Subjective Questionnaire of Mask Experience | 8.08 units on a scale | Standard Deviation 2.39 |
| Any Other Market Released Nasal or Nasal-pillow CPAP Mask | Subjective Questionnaire of Mask Experience | 8.12 units on a scale | Standard Deviation 2.37 |
Secondary
Mask Leak
The Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study.
Time frame: Every 10min, for up to 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPH Pilairo Q CPAP Mask | Mask Leak | 38.36 liters/minute | Standard Error 0.99 |
| Any Other Market Released Nasal or Nasal-pillow CPAP Mask | Mask Leak | 35.47 liters/minute | Standard Error 1.43 |
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.
Time frame: 1 night in the lab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPH Pilairo Q CPAP Mask | Sleep Technicians Recommendation to Use Mask | 8.83 units on a scale | Standard Deviation 1.47 |
| Any Other Market Released Nasal or Nasal-pillow CPAP Mask | Sleep Technicians Recommendation to Use Mask | 8.17 units on a scale | Standard Deviation 1.85 |