The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial

The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial

Sponsors

Lead sponsor: Fisher and Paykel Healthcare

Source Fisher and Paykel Healthcare
Brief Summary

This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington.

Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial.

This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.

Overall Status Completed
Start Date March 9, 2017
Completion Date April 15, 2017
Primary Completion Date March 30, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Comfort Up to 7 ± 3 days in-home
Stability Up to 7 ± 3 days in-home
Objective leak data Up to 7 ± 3 days in-home
Subjective measurement of leak Up to 7 ± 3 days in-home
Draft Up to 7 ± 3 days in-home
Treatment efficacy Up to 7 ± 3 days in-home
Noise Up to 7 ± 3 days in-home
Secondary Outcome
Measure Time Frame
Preference of mask Up to 7 ± 3 days in-home
Usability Up to 7 ± 3 days in-home
Enrollment 14
Condition
Intervention

Intervention type: Device

Intervention name: Saturn nasal mask

Description: Nasal mask for the treatment of obstructive sleep apnea (OSA)

Arm group label: Saturn nasal mask

Eligibility

Criteria:

Inclusion Criteria:

- Adult (18+ years of age)

- Able to give consent

- AHI ≥ 5 on diagnostic night

- Prescribed a CPAP device after successful OSA diagnosis

- Existing nasal or nasal pillow mask user

Exclusion Criteria:

- Inability to give consent

- Participants who are in a coma or a decreased level of consciousness.

- Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)

- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)

- Current diagnosis of CO2 retention

- Pregnant or may think they are pregnant.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Bowen Hospital
Location Countries

New Zealand

Verification Date

April 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Saturn nasal mask

Arm group type: Experimental

Description: Participants to use nasal mask in-home for 7 ± 3 days

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov