Obstructive Sleep Apnea
Conditions
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.
Detailed 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.
Interventions
DEVICEToffee 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.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toffee Mask Acceptability | 14±4 days in home | Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective |
| Toffee Mask Comfort | 14±4 days in home | Overall Toffee mask comfort determined from questionnaires-Subjective |
| Toffee Mask Treatment Seal Performance-Subjective | 14±4 days in home | Sealing performance of Toffee mask determined from questionnaires - Subjective |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toffee Mask Treatment Performance-Objective | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Toffee Full Face Mask |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 39 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 4 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Toffee Mask Acceptability
Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective
Time frame: 14±4 days in home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask | Toffee Mask Acceptability | Preferred Toffee mask | 27 Participants |
| Toffee Full Face Mask | Toffee Mask Acceptability | Preferred usual mask | 12 Participants |
Primary
Toffee Mask Comfort
Overall Toffee mask comfort determined from questionnaires-Subjective
Time frame: 14±4 days in home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask | Toffee Mask Comfort | Very comfortable | 15 Participants |
| Toffee Full Face Mask | Toffee Mask Comfort | Comfortable | 17 Participants |
| Toffee Full Face Mask | Toffee Mask Comfort | Neither comfortable nor uncomfortable | 3 Participants |
| Toffee Full Face Mask | Toffee Mask Comfort | Uncomfortable | 4 Participants |
| Toffee Full Face Mask | Toffee Mask Comfort | Very uncomfortable | 0 Participants |
Primary
Toffee Mask Treatment Seal Performance-Subjective
Sealing performance of Toffee mask determined from questionnaires - Subjective
Time frame: 14±4 days in home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask | Toffee Mask Treatment Seal Performance-Subjective | Very good | 14 Participants |
| Toffee Full Face Mask | Toffee Mask Treatment Seal Performance-Subjective | Good | 14 Participants |
| Toffee Full Face Mask | Toffee Mask Treatment Seal Performance-Subjective | Neither good nor poor | 9 Participants |
| Toffee Full Face Mask | Toffee Mask Treatment Seal Performance-Subjective | Poor | 2 Participants |
| Toffee Full Face Mask | Toffee Mask Treatment Seal Performance-Subjective | Very poor | 0 Participants |
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
Time frame: 14±4 days in home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask | Toffee Mask Treatment Performance-Objective | AHI decreased | 19 Participants |
| Toffee Full Face Mask | Toffee Mask Treatment Performance-Objective | AHI increased | 10 Participants |
| Toffee Full Face Mask | Toffee Mask Treatment Performance-Objective | N/A | 10 Participants |