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

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Toffee Nasal Pillows Mask

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ohio Sleep Medicine Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toffee Nasal Pillows Mask

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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

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

Trial Mask Acceptability

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03242148

First Posted

July 25, 2017

Last Updated

August 25, 2021

Sponsor

Fisher and Paykel Healthcare

Collaborators

Aspen Clinical Research

1. Study Identification

Unique Protocol Identification Number

NCT03242148

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 16, 2017 (Actual)

Primary Completion Date

November 3, 2017 (Actual)

Study Completion Date

November 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fisher and Paykel Healthcare

Collaborators

Aspen Clinical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Toffee Nasal Pillows Mask

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Toffee Nasal Pillows Mask

Intervention Description

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.

Primary Outcome Measure Information:

Title

Toffee Mask Usability

Description

Time Frame

14 ± 5 days in-Home

Title

Toffee Mask Comfort

Description

Time Frame

14 ± 5 days in-Home

Title

Toffee Mask Treatment Performance - Subjective

Description

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

Time Frame

14 ± 5 days in-Home

Title

Trial Mask Acceptability

Description

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

Time Frame

14 ± 5 days in-Home

Secondary Outcome Measure Information:

Title

Toffee Mask Treatment Performance - Objective

Description

Time Frame

14 ± 5 days in-Home

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asim Roy

Organizational Affiliation

Board Certified Sleep Specialist

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio Sleep Medicine Institute

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43017

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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