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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075722
• Other study ID #: CIA-205
• Status: Completed
• Phase: N/A
• First received: March 5, 2017
• Last updated: April 18, 2017
• Start date: March 9, 2017
• Est. completion date: April 15, 2017

Study information

• Verified date: April 2017
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 15, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing

Intervention

Device:
• Saturn nasal mask
Nasal mask for the treatment of obstructive sleep apnea (OSA)

Locations

Country	Name	City	State
New Zealand	Bowen Hospital	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	Subjective questionnaire	Up to 7 ± 3 days in-home
Primary	Stability	Subjective questionnaire	Up to 7 ± 3 days in-home
Primary	Objective leak data	Obtained from participant's CPAP device	Up to 7 ± 3 days in-home
Primary	Subjective measurement of leak	Subjective questionnaire	Up to 7 ± 3 days in-home
Primary	Draft	Subjective questionnaire	Up to 7 ± 3 days in-home
Primary	Treatment efficacy	Obtained from participant's CPAP device	Up to 7 ± 3 days in-home
Primary	Noise	Subjective questionnaire	Up to 7 ± 3 days in-home
Secondary	Preference of mask	Subjective questionnaire	Up to 7 ± 3 days in-home
Secondary	Usability	Subjective questionnaire	Up to 7 ± 3 days in-home