22 and older, any sex, with Positive Airway Pressure Therapy or Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comfort - SubjectivePrimary· Assessed 2 weeks after mask fitting
To assess the comfort of the mask as experienced by the participant. Comfort will be measured on a 4 point likert type scale (options: Very Uncomfortable, Uncomfortable, Comfortable, and Very Comfortable). Very Comfortable will be scored the highest and Very Uncomfortable will be scored the lowest. Different aspects of the mask such as cushion comfort, headgear comfort and overall comfort will be assessed using the same scale. Questions will be asked on a questionnaire and further qualitative responses will be captured during an interview.
Very comfortable
Group
Value
95% CI
Toffee Full Face Mask
18
Comfortable
Group
Value
95% CI
Toffee Full Face Mask
23
Uncomfortable
Group
Value
95% CI
Toffee Full Face Mask
2
Very uncomfortable
Group
Value
95% CI
Toffee Full Face Mask
1
UsabilityPrimary· Assessed 2 weeks after mask fitting
To assess the ease of use of the mask as experienced by the participant. Questions regarding the freedom of movement in bed will be asked using a 4 point likert type scale (options: Very Difficult, Difficult, Easy, and Very Easy). Very Easy will be scored the highest and Very Difficult will be scored the lowest. Questions will be asked via a questionnaire with additional qualitative responses captured during an interview.
Very easy
Group
Value
95% CI
Toffee Full Face Mask
19
Easy
Group
Value
95% CI
Toffee Full Face Mask
23
Difficult
Group
Value
95% CI
Toffee Full Face Mask
2
Very difficult
Group
Value
95% CI
Toffee Full Face Mask
0
Seal PerformancePrimary· Assessed 2 weeks after mask fitting
To assess the sealing performance of the mask when used in a home environment. Questions regarding the seal performance will be asked using a 4 point likert type scale (options: Very poor, Poor, Good, and Very good). Very good will be scored the highest and Very poor will be scored the lowest.
Very good
Group
Value
95% CI
Toffee Full Face Mask
25
Good
Group
Value
95% CI
Toffee Full Face Mask
15
Poor
Group
Value
95% CI
Toffee Full Face Mask
4
Very poor
Group
Value
95% CI
Toffee Full Face Mask
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected during the 2 week duration of the study period..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy by a physician. This clinical trial will take place across three investigation sites with a sample of 45 participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fisher and Paykel Healthcare
Last refreshed: 1 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04615832.