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Completed

NCT Number: NCT03726346

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

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.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Disease Specialists

Orlando, Florida, 34741, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Toffee Mask Acceptability

    Time frame: 14±4 days in home

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

  2. Toffee Mask Comfort

    Time frame: 14±4 days in home

    Overall Toffee mask comfort determined from questionnaires-Subjective

  3. Toffee Mask Treatment Seal Performance-Subjective

    Time frame: 14±4 days in home

    Sealing performance of Toffee mask determined from questionnaires - Subjective

Secondary outcomes

  1. Toffee Mask Treatment Performance-Objective

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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