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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Toffee Nasal Pillows Mask

• Registration Number: NCT03242148
• Lead Sponsor: Fisher and Paykel Healthcare

Brief 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)

Detailed Description

Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F\&P Toffee nasal pillows mask for use in-home.

The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the Toffee mask in home will be 14 ± 4 days from visit two.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-08-06
• Study First Posted: 2017-08-08
• Study Start: 2017-09-16
• Primary Completion: 2017-11-03
• Study Completion: 2017-11-03
• Disposition First Submitted: 2019-03-19
• Results First Submitted: 2021-04-05
• Results First Submitted QC: 2021-05-27
• Disposition First Submitted QC: 2021-05-27
• Results First Posted: 2021-06-01
• Disposition First Posted: 2021-06-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toffee Nasal Pillows Mask	Toffee Nasal Pillows Mask	Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm

Primary Outcome Measures

Name	Time	Method
Toffee Mask Usability	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.
Toffee Mask Comfort	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
Toffee Mask Treatment Performance - Subjective	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
Trial Mask Acceptability	14 ± 5 days in-Home	Participant count regarding whether they would continue using the trial mask if given the choice.

Secondary Outcome Measures

Name	Time	Method
Toffee Mask Treatment Performance - Objective	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.

Trial Locations

Locations (1)

Ohio Sleep Medicine Institute; 🇺🇸 Dublin, Ohio, United States