Obstructive Sleep Apnea
Conditions
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.
Interventions
DEVICEToffee full face mask with 'Improved Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
DEVICEToffee full face mask with 'Normal Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 F&P full face 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 |
|---|---|---|
| Trial Mask Seal Comfort | 7 ± 4 days in-home | Overall seal comfort determined from questionnaires- Subjective |
| Trial Mask Seal Acceptability | 14 ± 4 days in-home | Preference for trial mask determined from questionnaires at the end of the trial - Subjective |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Usability | 1 hour day-time appointment | Usability interview during first visit- Subjective |
| Trial Mask Seal Treatment Performance- Subjective | 7 ± 4 days in-home | Seal performance determined from questionnaires - Subjective |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Population Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Overall Population |
|---|---|
| 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 | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 38 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
Trial Mask Seal Acceptability
Preference for trial mask determined from questionnaires at the end of the trial - Subjective
Time frame: 14 ± 4 days in-home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Acceptability | Preferred Improved seal | 19 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Acceptability | Preferred Normal seal | 15 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Acceptability | No preference | 3 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Acceptability | N/A | 1 Participants |
Primary
Trial Mask Seal Comfort
Overall seal comfort determined from questionnaires- Subjective
Time frame: 7 ± 4 days in-home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Comfort | Comfortable | 16 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Comfort | Very comfortable | 16 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Comfort | Neither comfortable nor uncomfortable | 2 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Comfort | Uncomfortable | 3 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Comfort | Very uncomfortable | 0 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Comfort | N/A | 1 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Comfort | Very uncomfortable | 1 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Comfort | Uncomfortable | 3 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Comfort | Very comfortable | 13 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Comfort | Comfortable | 19 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Comfort | N/A | 1 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Comfort | Neither comfortable nor uncomfortable | 1 Participants |
Secondary
Trial Mask Seal Treatment Performance - Objective
Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data
Time frame: 7 ± 4 days in-home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance - Objective | Increased AHI | 10 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance - Objective | No change in AHI | 3 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance - Objective | Decreased AHI | 7 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance - Objective | N/A | 18 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance - Objective | N/A | 17 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance - Objective | Increased AHI | 6 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance - Objective | Decreased AHI | 11 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance - Objective | No change in AHI | 4 Participants |
Secondary
Trial Mask Seal Treatment Performance- Subjective
Seal performance determined from questionnaires - Subjective
Time frame: 7 ± 4 days in-home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance- Subjective | Poor | 3 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance- Subjective | Very poor | 1 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance- Subjective | Very good | 19 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance- Subjective | Good | 11 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance- Subjective | Neither good nor poor | 3 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Treatment Performance- Subjective | N/A | 1 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance- Subjective | Neither good nor poor | 4 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance- Subjective | Poor | 2 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance- Subjective | Good | 12 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance- Subjective | Very poor | 2 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance- Subjective | N/A | 1 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Treatment Performance- Subjective | Very good | 17 Participants |
Secondary
Trial Mask Seal Usability
Usability interview during first visit- Subjective
Time frame: 1 hour day-time appointment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Usability | Very easy | 28 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Usability | Easy | 8 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Usability | Neither easy nor difficult | 0 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Usability | Difficult | 0 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Usability | Very difficult | 0 Participants |
| Toffee Full Face Mask With 'Improved Seal' | Trial Mask Seal Usability | N/A | 2 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Usability | Very difficult | 0 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Usability | Very easy | 26 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Usability | Difficult | 1 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Usability | Easy | 7 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Usability | N/A | 2 Participants |
| Toffee Full Face Mask With 'Normal Seal' | Trial Mask Seal Usability | Neither easy nor difficult | 2 Participants |