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 participants who currently use a nasal, sub-nasal or pillows mask will be recruited. The study will involve a baseline (Visit 1) 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 by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.
Interventions
DEVICEDevice: Trial nasal mask (F&P)
This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.
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
* Diagnosis of OSA by Physician * ≥ 22 years of age * ≥ 66 lbs * Prescribed PAP or BPAP therapy for OSA * Existing nasal, sub-nasal and pillows mask users * Fluent in written and spoken English
Exclusion criteria
* Inability to give informed consent * Pregnant or think they may be pregnant * PAP Intolerant * Anatomical or Physiological Conditions that make PAP inappropriate * IPAP pressure of ≤25cmH20. * PAP/BPAP therapy device without data recording capabilities * Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Objective Trial Mask Performance | 14 ± 3 days in home | Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device. Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F&P nasal mask. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Trial Mask Overall Simplicity of Use | 14 ± 3 days in home | Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring ease of use, from very simple, simple, average, challenging, very challenging). Results below represent percentage of respondents for each value. |
| Number of Participants Subjective Trial Mask Comfort | 14 ± 3 days in home | Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring comfort from very comfortable, comfortable, average, uncomfortable, very uncomfortable). Participants reported their subject views on mask comfort. Responses to each likert scale option are presented below as percentages. |
| Number of Participants Overall Trial Mask Satisfaction | 14 ± 3 days in home | Determined from questionnaires and a sleep diary - Subjective (measuring overall mask satisfaction, includes discussion, questions around overall satisfaction and preference of the new F&P Nasal mask compared to participants' usual mask ). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Experimental Trial Nasal Mask Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.
Device: Trial nasal mask (F&P): This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Age, Customized Age 22+ years | 45 Participants |
| Race/Ethnicity, Customized Caucasian | 32 Participants |
| Race/Ethnicity, Customized Other ethnicity (Hispanic/African American/Asian/Polynesian Descent | 13 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 5 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Number of Participants Objective Trial Mask Performance
Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device. Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F&P nasal mask.
Time frame: 14 ± 3 days in home
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Experimental Trial Nasal Mask | Number of Participants Objective Trial Mask Performance | 42 Participants |
Secondary
Number of Participants Overall Trial Mask Satisfaction
Determined from questionnaires and a sleep diary - Subjective (measuring overall mask satisfaction, includes discussion, questions around overall satisfaction and preference of the new F&P Nasal mask compared to participants' usual mask ).
Time frame: 14 ± 3 days in home
Population: A data size of 44 was used for this analysis due to missing data for one participant.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Experimental Trial Nasal Mask | Number of Participants Overall Trial Mask Satisfaction | Preferred F&P nasal mask | 24 Participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Overall Trial Mask Satisfaction | Did not prefer F&P nasal mask | 20 Participants |
Secondary
Number of Participants Subjective Trial Mask Comfort
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring comfort from very comfortable, comfortable, average, uncomfortable, very uncomfortable). Participants reported their subject views on mask comfort. Responses to each likert scale option are presented below as percentages.
Time frame: 14 ± 3 days in home
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Experimental Trial Nasal Mask | Number of Participants Subjective Trial Mask Comfort | Average | 11 percentage of participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Subjective Trial Mask Comfort | Very comfortable | 39 percentage of participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Subjective Trial Mask Comfort | Comfortable | 37 percentage of participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Subjective Trial Mask Comfort | Uncomfortable | 11 percentage of participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Subjective Trial Mask Comfort | Very uncomfortable | 2 percentage of participants |
Secondary
Number of Participants Trial Mask Overall Simplicity of Use
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring ease of use, from very simple, simple, average, challenging, very challenging). Results below represent percentage of respondents for each value.
Time frame: 14 ± 3 days in home
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Experimental Trial Nasal Mask | Number of Participants Trial Mask Overall Simplicity of Use | Very Simple | 53 percentage of participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Trial Mask Overall Simplicity of Use | Simple | 36 percentage of participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Trial Mask Overall Simplicity of Use | Average | 2 percentage of participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Trial Mask Overall Simplicity of Use | Challenging | 7 percentage of participants |
| Experimental: Experimental Trial Nasal Mask | Number of Participants Trial Mask Overall Simplicity of Use | Very Challenging | 2 percentage of participants |