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

Not Applicable

Completed

• Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea
• Interventions: Device: Saturn nasal mask

• Registration Number: NCT03075722
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-05
• Study First Submitted QC: 2017-03-05
• Study Start: 2017-03-09
• Study First Posted: 2017-03-09
• Primary Completion: 2017-03-30
• Status Verified: 2017-04
• Study Completion: 2017-04-15
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saturn nasal mask	Saturn nasal mask	Participants to use nasal mask in-home for 7 ± 3 days

Primary Outcome Measures

Name	Time	Method
Draft	Up to 7 ± 3 days in-home	Subjective questionnaire
Noise	Up to 7 ± 3 days in-home	Subjective questionnaire
Treatment efficacy	Up to 7 ± 3 days in-home	Obtained from participant's CPAP device
Comfort	Up to 7 ± 3 days in-home	Subjective questionnaire
Subjective measurement of leak	Up to 7 ± 3 days in-home	Subjective questionnaire
Objective leak data	Up to 7 ± 3 days in-home	Obtained from participant's CPAP device
Stability	Up to 7 ± 3 days in-home	Subjective questionnaire

Secondary Outcome Measures

Name	Time	Method
Preference of mask	Up to 7 ± 3 days in-home	Subjective questionnaire
Usability	Up to 7 ± 3 days in-home	Subjective questionnaire

Trial Locations

Locations (1)

Bowen Hospital; 🇳🇿 Wellington, New Zealand