An interventional study of Trial Nasal Mask in Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare. Completed at 2 sites in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.
This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.
Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 39 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participant will use the Saturn nasal mask for 2 weeks in home
Device: Trial Nasal Mask
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
Time frame: 2 weeks in home
Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.
the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"
Time frame: 2 weeks in home
Objective leak data through the Positive Airway Pressure therapy device
Evaluating the leak of the trial Nasal mask
Time frame: 2 weeks in home
Treatment efficacy through the Positive Airway Pressure therapy device
Evaluating the number of apnea/hypopnea per hour
Time frame: 2 weeks in home
Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.
the participant would either choose the trial Nasal mask or their usual mask as their primary mask
Time frame: 2 weeks in home
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fisher and Paykel Healthcare