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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Toffee Full Face Mask

• Registration Number: NCT03726346
• 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 mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.

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 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 Timeline

• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2018-11-26
• Primary Completion: 2018-12-13
• Disposition First Submitted: 2019-04-07
• Study Completion: 2019-11-13
• Status Verified: 2022-05
• Results First Submitted: 2022-05-02
• Results First Submitted QC: 2022-05-25
• Disposition First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Results First Posted: 2022-06-21
• Disposition First Posted: 2022-06-21
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toffee Full Face Mask	Toffee Full Face Mask	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.

Primary Outcome Measures

Name	Time	Method
Toffee Mask Treatment Seal Performance-Subjective	14±4 days in home	Sealing performance of Toffee mask determined from questionnaires - Subjective
Toffee Mask Acceptability	14±4 days in home	Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective
Toffee Mask Comfort	14±4 days in home	Overall Toffee mask comfort determined from questionnaires-Subjective

Secondary Outcome Measures

Name	Time	Method
Toffee Mask Treatment Performance-Objective	14±4 days in home	Objective Apnea Hypopnea Index (AHI) data recorded from the participants Positive Airway Pressure (PAP) device and compared to baseline AHI data - Objective

Trial Locations

Locations (1)

Pulmonary Disease Specialists; 🇺🇸 Orlando, Florida, United States