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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726346
• Other study ID #: CIA 243
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: November 13, 2019

Study information

• Verified date: May 2022
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 13, 2019
• Est. primary completion date: December 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Pulmonary Disease Specialists	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toffee Mask Acceptability	Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective	14±4 days in home
Primary	Toffee Mask Comfort	Overall Toffee mask comfort determined from questionnaires-Subjective	14±4 days in home
Primary	Toffee Mask Treatment Seal Performance-Subjective	Sealing performance of Toffee mask determined from questionnaires - Subjective	14±4 days in home
Secondary	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	14±4 days in home