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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03242148

Enrollment

Registered

2017-08-08

Start date

2017-09-16

Completion date

2017-11-03

Last updated

2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

DEVICEToffee 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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 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.	38
Total	38

Baseline characteristics

Characteristic	Toffee Nasal Pillows Mask
Age, Customized 22-35	0 Participants
Age, Customized 36-45	5 Participants
Age, Customized 46-55	3 Participants
Age, Customized 56-65	10 Participants
Age, Customized 66-75	14 Participants
Age, Customized 76-85	6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Region of Enrollment United States	38 Participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	24 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 38
other Total, other adverse events	8 / 38
serious Total, serious adverse events	0 / 38

Outcome results

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