NCT03272763 is a NA clinical trial of F&P Toffee mask in Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare.

Who is sponsoring NCT03272763?

NCT03272763 is sponsored by Fisher and Paykel Healthcare.

What drugs are being tested in NCT03272763?

Interventions in NCT03272763: F&P Toffee mask.

What condition does NCT03272763 study?

NCT03272763 studies Obstructive Sleep Apnea.

Is NCT03272763 still recruiting?

NCT03272763 is currently completed. Last updated 21 June 2022.

Are results published for NCT03272763?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-06-21 · How we verify

NCT03272763

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

Completed NA Results posted Last updated 21 June 2022

What this trial tests

NA trial testing F&P Toffee mask in Obstructive Sleep Apnea in 38 participants. Completed in 9 October 2018.

Timeline

9 October 2017

Primary endpoint
29 October 2017

9 October 2018

Quick facts

Lead sponsor	Fisher and Paykel Healthcare
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	9 October 2017
Primary completion	29 October 2017
Estimated completion	9 October 2018
Sites	1 location across United States

Drugs / interventions tested

F&P Toffee mask

Conditions studied

Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Fisher and Paykel Healthcare — full company profile →

Who can join

22 and older, any sex, with 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.

Trial Mask Comfort Primary · 14 ± 5 days In-Home

Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective

Much better

Group	Value	95% CI
F&P Toffee Mask	7

Better

Group	Value	95% CI
F&P Toffee Mask	13

Same

Group	Value	95% CI
F&P Toffee Mask	3

Worse

Group	Value	95% CI
F&P Toffee Mask	12

Much worse

Group	Value	95% CI
F&P Toffee Mask	3

Trial Mask Performance - Objective Primary · 14 ± 5 days In-Home

Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective

Increased leak

Group	Value	95% CI
F&P Toffee Mask	9

Same leak

Group	Value	95% CI
F&P Toffee Mask	3

Decreased leak

Group	Value	95% CI
F&P Toffee Mask	9

N/A

Group	Value	95% CI
F&P Toffee Mask	17

Trial Mask Performance - Subjective Primary · 14 ± 5 days In-Home

Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective

Much better

Group	Value	95% CI
F&P Toffee Mask	9

Better

Group	Value	95% CI
F&P Toffee Mask	8

Same

Group	Value	95% CI
F&P Toffee Mask	10

Worse

Group	Value	95% CI
F&P Toffee Mask	10

Much worse

Group	Value	95% CI
F&P Toffee Mask	1

Trial Mask Usability Primary · During Visit Two - 20 minutes

Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective

Both orientation and positioning

Group	Value	95% CI
F&P Toffee Mask	17

Orientation only

Group	Value	95% CI
F&P Toffee Mask	25

Neither

Group	Value	95% CI
F&P Toffee Mask	1

Trial Mask Ease-of-Use Primary · 14 ± 5 days In-Home

Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective

Much better

Group	Value	95% CI
F&P Toffee Mask	7

Better

Group	Value	95% CI
F&P Toffee Mask	14

Same

Group	Value	95% CI
F&P Toffee Mask	13

Worse

Group	Value	95% CI
F&P Toffee Mask	3

Much worse

Group	Value	95% CI
F&P Toffee Mask	1

Mask Leak Data Secondary · 14 ± 5 days In-Home

Leak data recorded from PAP device - Objective

Leak increased

Group	Value	95% CI
F&P Toffee Mask	1

Leak remained the same

Group	Value	95% CI
F&P Toffee Mask	3

Leak decreased

Group	Value	95% CI
F&P Toffee Mask	10

No data

Group	Value	95% CI
F&P Toffee Mask	6

Seal Size Determination Secondary · 1 day-time appointment (1 hour) during Visit Two

Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.

Yes

Group	Value	95% CI
F&P Toffee Mask	36

Group	Value	95% CI
F&P Toffee Mask	2

Efficacy Data Secondary · 14 ± 5 days In-Home

AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective

AHI increased

Group	Value	95% CI
F&P Toffee Mask	18

AHI remained the same

Group	Value	95% CI
F&P Toffee Mask	3

AHI decreased

Group	Value	95% CI
F&P Toffee Mask	14

No data

Group	Value	95% CI
F&P Toffee Mask	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for all participants for 1 year from the date informed consent was obtained.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

F&P Toffee Mask

Serious: 0/38 (0%)

Deaths: 0/38

Other adverse events (1 terms — click to expand)

Reaction	System	F&P Toffee Mask
Nasal congestion and sore	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03272763 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting

Other Fisher and Paykel Healthcare trials

Trials by the same sponsor.

NCT07484802 — Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask. · NA · not yet recruiting
NCT06939920 — NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation · NA · not yet recruiting
NCT06738589 — The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway · NA · not yet recruiting
NCT06670482 — The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation · NA · completed
NCT06060717 — Evaluation of the F&P Caramel Nasal Mask, US, 2023 · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03272763 (US National Library of Medicine, public domain)
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: 21 June 2022

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/NCT03272763.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03272763

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Obstructive Sleep Apnea

Other Fisher and Paykel Healthcare trials

Verify against primary sources