The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- Fisher and Paykel Healthcare
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Number of Participants Objective Trial Mask Performance
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed Description
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited. The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of OSA by Physician
- •≥ 22 years of age
- •Prescribed PAP or BPAP therapy for OSA
- •Existing nasal, sub-nasal and pillows mask users
- •Fluent in written and spoken English
Exclusion Criteria
- •Inability to give informed consent
- •Pregnant or think they may be pregnant
- •PAP Intolerant
- •Anatomical or Physiological Conditions that make PAP inappropriate
- •IPAP pressure of ≤25cmH
- •PAP/BPAP therapy device without data recording capabilities
- •Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Outcomes
Primary Outcomes
Number of Participants Objective Trial Mask Performance
Time Frame: 14 ± 3 days in home
Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device. Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F\&P nasal mask.
Secondary Outcomes
- Number of Participants Subjective Trial Mask Comfort(14 ± 3 days in home)
- Number of Participants Trial Mask Overall Simplicity of Use(14 ± 3 days in home)
- Number of Participants Overall Trial Mask Satisfaction(14 ± 3 days in home)