NCT03242148

The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Completed NA Results posted Last updated 22 September 2021

What this trial tests

NA trial testing Toffee Nasal Pillows Mask in Obstructive Sleep Apnea in 38 participants. Completed in 3 November 2017.

Timeline

16 September 2017

Primary endpoint
3 November 2017

3 November 2017

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	16 September 2017
Primary completion	3 November 2017
Estimated completion	3 November 2017
Sites	1 location across United States

Drugs / interventions tested

• Toffee Nasal Pillows 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.

Toffee Mask Usability Primary · 14 ± 5 days in-Home

Questionnaire on usability during second visit - Subjective. Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.

Group	Value	95% CI
Toffee Nasal Pillows Mask	33
Toffee Nasal Pillows Mask	1
Toffee Nasal Pillows Mask	4

Toffee Mask Comfort Primary · 14 ± 5 days in-Home

Determine from questionnaires - Subjective Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor

Group	Value	95% CI
Toffee Nasal Pillows Mask	31
Toffee Nasal Pillows Mask	2
Toffee Nasal Pillows Mask	5

Toffee Mask Treatment Performance - Subjective Primary · 14 ± 5 days in-Home

Determined from questionnaires - Subjective Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor

Group	Value	95% CI
Toffee Nasal Pillows Mask	30
Toffee Nasal Pillows Mask	4
Toffee Nasal Pillows Mask	4

Trial Mask Acceptability Primary · 14 ± 5 days in-Home

Participant count regarding whether they would continue using the trial mask if given the choice.

Yes

Group	Value	95% CI
Toffee Nasal Pillows Mask	27

No

Group	Value	95% CI
Toffee Nasal Pillows Mask	11

Toffee Mask Treatment Performance - Objective Secondary · 14 ± 5 days in-Home

Objective data recorded from PAP device - Objective Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a "pass" or "fail" based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail.

Group	Value	95% CI
Toffee Nasal Pillows Mask	34
Toffee Nasal Pillows Mask	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for all participants for 1 year from the date informed consent was obtained.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Toffee Nasal Pillows Mask

Serious: 0/38 (0%)

Deaths: 0/38

Other adverse events (2 terms — click to expand)

Reaction	System	Toffee Nasal Pillows Mask
Nasal Irritation	Skin and subcutaneous tissue disorders	—
Sore on the top of the head	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03242148 adverse events section.

Sponsor's own description

This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)

Publications & conference data

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