The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Completed

Interventions: Device: Toffee full face mask with 'Improved Seal'
Device: Toffee full face mask with 'Normal Seal'

Brief Summary: The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

Detailed Description: This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.

The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.

Visit Three will involve the participants returning the second trial seal and providing feedback.

Recruitment & 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 F&P full face mask user

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Group B	Toffee full face mask with 'Improved Seal'	Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Group A	Toffee full face mask with 'Improved Seal'	Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Group A	Toffee full face mask with 'Normal Seal'	Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Group B	Toffee full face mask with 'Normal Seal'	Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.

Primary Outcome Measures

Name	Time	Method
Trial Mask Seal Acceptability	14 ± 4 days in-home	Preference for trial mask determined from questionnaires at the end of the trial - Subjective
Trial Mask Seal Comfort	7 ± 4 days in-home	Overall seal comfort determined from questionnaires- Subjective

Secondary Outcome Measures

Name	Time	Method
Trial Mask Seal Usability	1 hour day-time appointment	Usability interview during first visit- Subjective
Trial Mask Seal Treatment Performance - Objective	7 ± 4 days in-home	Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data
Trial Mask Seal Treatment Performance- Subjective	7 ± 4 days in-home	Seal performance determined from questionnaires - Subjective