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

NCT03726346 | Completed Results DMC FDA Device

• 1 other identifier: CIA 243
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Toffee Mask Acceptability

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

  14±4 days in home

• Toffee Mask Comfort

  Overall Toffee mask comfort determined from questionnaires-Subjective

  14±4 days in home

• Toffee Mask Treatment Seal Performance-Subjective

  Sealing performance of Toffee mask determined from questionnaires - Subjective

  14±4 days in home

Secondary Outcomes (1)

• Toffee Mask Treatment Performance-Objective

  14±4 days in home

Study Arms (1)

Toffee Full Face Mask

EXPERIMENTAL

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.

Device: Toffee Full Face Mask

Interventions

Toffee Full Face Mask DEVICE

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.

Toffee Full Face Mask

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Pulmonary Disease Specialists

Orlando, Florida, 34741, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Bhavi Ogra
• Organization: Fisher & Paykel Healthcare Ltd.

bhavi.ogra@fphcare.co.nz

+64 9 574 0123

Study Officials

• Catherine Goodwin

  Research Director

  STUDY DIRECTOR

• Thomas O'Brien, MD

  Pulmonologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: October 31, 2018
• Study Start: November 26, 2018
• Primary Completion: December 13, 2018
• Study Completion: November 13, 2019
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)