N/A Completed N=38 Treatment

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

Obstructive Sleep Apnea

Source: ClinicalTrials.gov NCT03242148 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcomePrimary: Toffee Mask Usability — 33; 1; 4 Participants

Summary

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)

Outcome Measures

Outcome	Result	p-value
PRIMARY Toffee Mask Usability	33; 1; 4	—
PRIMARY Toffee Mask Comfort	31; 2; 5	—
PRIMARY Toffee Mask Treatment Performance - Subjective	30; 4; 4	—
PRIMARY Trial Mask Acceptability	27; 11	—
SECONDARY Toffee Mask Treatment Performance - Objective	34; 0	—

Eligibility Criteria

Inclusion Criteria

Adult (22+ years of age)
Able to give informed consent
Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
Fluent in spoken and written English
Existing nasal pillows mask user

Exclusion Criteria

Inability to give informed consent
Participant intolerant to PAP
Anatomical or physiological conditions making PAP therapy inappropriate
Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
Pregnant or may think they are pregnant.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03242148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.