The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Comfort
Study Overview
Brief Summary
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher & Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher & Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (18+ years of age)
- •Able to give consent
- •Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
- •Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
- •Existing nasal or nasal pillow mask user
Exclusion Criteria
- •Inability to give consent
- •Patients 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.
Arms & Interventions
Trial Nasal Mask
Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography.
Intervention: Trial Nasal mask (Device)
Outcomes
Primary Outcomes
Comfort
Time Frame: Up to 1 week in-home
Subjective Questionnaire
Draft
Time Frame: Up to 1 week in-home
Subjective Questionnaire
Objective leak data (L/min)
Time Frame: 1 night
Obtained from the overnight polysomnography
Subjective measurement of leak
Time Frame: Up to 1 week in-home
Subjective Questionnaire
Stability
Time Frame: Up to 1 week in-home
Subjective Questionnaire
Noise
Time Frame: Up to 1 week in-home
Subjective Questionnaire
Secondary Outcomes
- Preference of the mask(Up to 1 week in-home)