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

Fisher and Paykel Healthcare39 enrolled

Overview

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 mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.

Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F\&P Toffee 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 2 weeks of the beginning of the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Toffee Full Face MaskDEVICE

Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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 OSA 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.

Locations (1)

Pulmonary Disease Specialists

Orlando, Florida, United States

Outcomes

Primary Outcomes

Toffee Mask Acceptability

Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective

Time frame: 14±4 days in home

Toffee Mask Comfort

Overall Toffee mask comfort determined from questionnaires-Subjective

Time frame: 14±4 days in home

Toffee Mask Treatment Seal Performance-Subjective

Sealing performance of Toffee mask determined from questionnaires - Subjective

Time frame: 14±4 days in home

Secondary Outcomes

Toffee Mask Treatment Performance-Objective

Objective Apnea Hypopnea Index (AHI) data recorded from the participants Positive Airway Pressure (PAP) device and compared to baseline AHI data - Objective

Time frame: 14±4 days in home

Data from ClinicalTrials.gov

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