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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242148
• Other study ID #: CIA 219
• Status: Completed
• Phase: N/A
• Start date: September 16, 2017
• Est. completion date: November 3, 2017

Study information

• Verified date: August 2021
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Toffee Nasal Pillows Mask
Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.

Locations

Country	Name	City	State
United States	Ohio Sleep Medicine Institute	Dublin	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare	Aspen Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toffee Mask Usability	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.	14 ± 5 days in-Home
Primary	Toffee Mask Comfort	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	14 ± 5 days in-Home
Primary	Toffee Mask Treatment Performance - Subjective	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	14 ± 5 days in-Home
Primary	Trial Mask Acceptability	Participant count regarding whether they would continue using the trial mask if given the choice.	14 ± 5 days in-Home
Secondary	Toffee Mask Treatment Performance - Objective	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.	14 ± 5 days in-Home