An interventional study of Trial Nasal mask in Sleep Disordered Breathing and Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare. Completed at 1 site in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-17.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment
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.
1,422 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's enrollment of 12 is below the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea 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:
Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography.
Device: Trial Nasal mask
Nasal mask for the treatment of obstructive sleep apnea (OSA)
Objective leak data (L/min)
Obtained from the participant's device
Time frame: Up to 1 week in-home
Subjective measurement of leak
Subjective Questionnaire
Time frame: Up to 1 week in-home
Comfort
Subjective Questionnaire
Time frame: Up to 1 week in-home
Stability
Subjective Questionnaire
Time frame: Up to 1 week in-home
Draft
Subjective Questionnaire
Time frame: Up to 1 week in-home
Noise
Subjective Questionnaire
Time frame: Up to 1 week in-home
Objective leak data (L/min)
Obtained from the overnight polysomnography
Time frame: 1 night
Preference of the mask
Subjective Questionnaire
Time frame: Up to 1 week in-home
Plan to share: No — For product development purposes only. Data will be deidentified.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Fisher and Paykel Healthcare