Obstructive Sleep Apnea
Conditions
Brief summary
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed description
This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited. This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two. The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea. Neither the investigators nor the participants will be blinded to the study.
Interventions
DEVICEF&P Toffee mask
Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After a period of baseline, all enrolled participants will be put on the same trial mask.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AHI ≥ 5 from the diagnostic night * Aged 22 and over (FDA defined as default) * Either prescribed APAP, CPAP or Bi-level PAP for OSA * Existing Full-Face mask user * Fluent in spoken and written English
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 CO2 retention * Pregnant or think they may be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trial Mask Ease-of-Use | 14 ± 5 days In-Home | Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective |
| Trial Mask Performance - Objective | 14 ± 5 days In-Home | Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective |
| Trial Mask Performance - Subjective | 14 ± 5 days In-Home | Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective |
| Trial Mask Usability | During Visit Two - 20 minutes | Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective |
| Trial Mask Comfort | 14 ± 5 days In-Home | Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seal Size Determination | 1 day-time appointment (1 hour) during Visit Two | Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant. |
| Efficacy Data | 14 ± 5 days In-Home | AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective |
| Mask Leak Data | 14 ± 5 days In-Home | Leak data recorded from PAP device - Objective |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| F&P Toffee Mask Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | F&P Toffee Mask |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 38 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 2 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Trial Mask Comfort
Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Mask | Trial Mask Comfort | Much better | 7 Participants |
| F&P Toffee Mask | Trial Mask Comfort | Better | 13 Participants |
| F&P Toffee Mask | Trial Mask Comfort | Same | 3 Participants |
| F&P Toffee Mask | Trial Mask Comfort | Worse | 12 Participants |
| F&P Toffee Mask | Trial Mask Comfort | Much worse | 3 Participants |
Primary
Trial Mask Ease-of-Use
Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Mask | Trial Mask Ease-of-Use | Worse | 3 Participants |
| F&P Toffee Mask | Trial Mask Ease-of-Use | Much worse | 1 Participants |
| F&P Toffee Mask | Trial Mask Ease-of-Use | Better | 14 Participants |
| F&P Toffee Mask | Trial Mask Ease-of-Use | Same | 13 Participants |
| F&P Toffee Mask | Trial Mask Ease-of-Use | Much better | 7 Participants |
Primary
Trial Mask Performance - Objective
Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Mask | Trial Mask Performance - Objective | Increased leak | 9 Participants |
| F&P Toffee Mask | Trial Mask Performance - Objective | Same leak | 3 Participants |
| F&P Toffee Mask | Trial Mask Performance - Objective | Decreased leak | 9 Participants |
| F&P Toffee Mask | Trial Mask Performance - Objective | N/A | 17 Participants |
Primary
Trial Mask Performance - Subjective
Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Mask | Trial Mask Performance - Subjective | Much better | 9 Participants |
| F&P Toffee Mask | Trial Mask Performance - Subjective | Better | 8 Participants |
| F&P Toffee Mask | Trial Mask Performance - Subjective | Same | 10 Participants |
| F&P Toffee Mask | Trial Mask Performance - Subjective | Worse | 10 Participants |
| F&P Toffee Mask | Trial Mask Performance - Subjective | Much worse | 1 Participants |
Primary
Trial Mask Usability
Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective
Time frame: During Visit Two - 20 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Mask | Trial Mask Usability | Both orientation and positioning | 17 Participants |
| F&P Toffee Mask | Trial Mask Usability | Orientation only | 25 Participants |
| F&P Toffee Mask | Trial Mask Usability | Neither | 1 Participants |
Secondary
Efficacy Data
AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Mask | Efficacy Data | AHI increased | 18 Participants |
| F&P Toffee Mask | Efficacy Data | AHI decreased | 14 Participants |
| F&P Toffee Mask | Efficacy Data | No data | 3 Participants |
| F&P Toffee Mask | Efficacy Data | AHI remained the same | 3 Participants |
Secondary
Mask Leak Data
Leak data recorded from PAP device - Objective
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Mask | Mask Leak Data | Leak remained the same | 3 Participants |
| F&P Toffee Mask | Mask Leak Data | Leak decreased | 10 Participants |
| F&P Toffee Mask | Mask Leak Data | No data | 6 Participants |
| F&P Toffee Mask | Mask Leak Data | Leak increased | 1 Participants |
Secondary
Seal Size Determination
Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.
Time frame: 1 day-time appointment (1 hour) during Visit Two
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Mask | Seal Size Determination | Yes | 36 Participants |
| F&P Toffee Mask | Seal Size Determination | No | 2 Participants |