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
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited This study will involve a baseline (Visit One) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give 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 loan 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 Obstructive Sleep Apnea. Neither the investigators nor the participants will be blinded to the study.
Interventions
DEVICEF&P Saturn
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AHI ≥ 5 from diagnostic PSG night * Aged 22 and over (FDA defined as adult) * Either prescribed APAP, CPAP or Bi-Level PAP for OSA * Existing nasal or nasal pillows mask users (preferable 70%:30% split) * Fluent in spoken and written English
Exclusion criteria
* Inability to give informed consent * Patient intolerant to CPAP therapy * 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 |
|---|---|---|
| Number of Participants PAP Device Performance Reporting | 14 ± 5 days In-Home | Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea |
| Number of Participants Subjective Reporting of Nasal Mask Usability | During Visit Two - 20 minutes | Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea |
| Number of Participants Subjective Recording of Ease of Nasal Mask Use. | 14 ± 5 days In-Home | Ease of use reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea |
| Number of Participants Reporting Comfort Compared to Their Usual Mask. | 14 ± 5 days In-Home | Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea |
| Number of Participants Subjective Performance Rating of the Nasal Mask | 14 ± 5 days In-Home | Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Correct Nasal Mask Size Determination | 1 day-time appointment (1 hour) | Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea |
| Number of Participants Leak Compared to Usual Mask | 14 ± 5 days In-Home | Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| F&P Nasal Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | F&P Nasal |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Number of Participants PAP Device Performance Reporting
Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Nasal | Number of Participants PAP Device Performance Reporting | Better than usual mask | 9 Participants |
| F&P Nasal | Number of Participants PAP Device Performance Reporting | Same as usual mask | 13 Participants |
| F&P Nasal | Number of Participants PAP Device Performance Reporting | Worse than usual mask | 2 Participants |
| F&P Nasal | Number of Participants PAP Device Performance Reporting | No data | 13 Participants |
Primary
Number of Participants Reporting Comfort Compared to Their Usual Mask.
Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Nasal | Number of Participants Reporting Comfort Compared to Their Usual Mask. | Much better | 17 Participants |
| F&P Nasal | Number of Participants Reporting Comfort Compared to Their Usual Mask. | Better | 4 Participants |
| F&P Nasal | Number of Participants Reporting Comfort Compared to Their Usual Mask. | Same | 9 Participants |
| F&P Nasal | Number of Participants Reporting Comfort Compared to Their Usual Mask. | Worse | 6 Participants |
| F&P Nasal | Number of Participants Reporting Comfort Compared to Their Usual Mask. | Much Worse | 1 Participants |
Primary
Number of Participants Subjective Performance Rating of the Nasal Mask
Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Nasal | Number of Participants Subjective Performance Rating of the Nasal Mask | Very good | 23 Participants |
| F&P Nasal | Number of Participants Subjective Performance Rating of the Nasal Mask | Good | 6 Participants |
| F&P Nasal | Number of Participants Subjective Performance Rating of the Nasal Mask | Acceptable | 4 Participants |
| F&P Nasal | Number of Participants Subjective Performance Rating of the Nasal Mask | Poor | 4 Participants |
| F&P Nasal | Number of Participants Subjective Performance Rating of the Nasal Mask | Very Poor | 0 Participants |
Primary
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Ease of use reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Nasal | Number of Participants Subjective Recording of Ease of Nasal Mask Use. | Very Easy | 23 Participants |
| F&P Nasal | Number of Participants Subjective Recording of Ease of Nasal Mask Use. | Easy | 9 Participants |
| F&P Nasal | Number of Participants Subjective Recording of Ease of Nasal Mask Use. | Acceptable | 5 Participants |
| F&P Nasal | Number of Participants Subjective Recording of Ease of Nasal Mask Use. | Difficult | 0 Participants |
| F&P Nasal | Number of Participants Subjective Recording of Ease of Nasal Mask Use. | Very Difficult | 0 Participants |
Primary
Number of Participants Subjective Reporting of Nasal Mask Usability
Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time frame: During Visit Two - 20 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Nasal | Number of Participants Subjective Reporting of Nasal Mask Usability | Very Easy | 23 Participants |
| F&P Nasal | Number of Participants Subjective Reporting of Nasal Mask Usability | Easy | 9 Participants |
| F&P Nasal | Number of Participants Subjective Reporting of Nasal Mask Usability | Acceptable | 5 Participants |
| F&P Nasal | Number of Participants Subjective Reporting of Nasal Mask Usability | Difficult | 0 Participants |
| F&P Nasal | Number of Participants Subjective Reporting of Nasal Mask Usability | Very Difficult | 0 Participants |
Secondary
Number of Participants Leak Compared to Usual Mask
Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time frame: 14 ± 5 days In-Home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Nasal | Number of Participants Leak Compared to Usual Mask | No Data | 13 Participants |
| F&P Nasal | Number of Participants Leak Compared to Usual Mask | Better than current mask | 9 Participants |
| F&P Nasal | Number of Participants Leak Compared to Usual Mask | Same as current mask | 13 Participants |
| F&P Nasal | Number of Participants Leak Compared to Usual Mask | Worse than current mask | 2 Participants |
Secondary
Number of Participants With Correct Nasal Mask Size Determination
Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time frame: 1 day-time appointment (1 hour)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Nasal | Number of Participants With Correct Nasal Mask Size Determination | Correct | 22 Participants |
| F&P Nasal | Number of Participants With Correct Nasal Mask Size Determination | In between sizes | 6 Participants |
| F&P Nasal | Number of Participants With Correct Nasal Mask Size Determination | Incorrect | 9 Participants |