An interventional study of Device: Trial nasal mask (F&P) in Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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: 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.
Also known as: New nasal mask
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
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
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
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
| Milestone | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Started | 45 |
| Completed | 45 |
| Not completed | 0 |
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.
| Participants | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Number of Participants Objective Trial Mask Performance | 42 |
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.
| percentage of participants | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Very Simple | 53 |
| Simple | 36 |
| Average | 2 |
| Challenging | 7 |
| Very Challenging | 2 |
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.
| percentage of participants | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Very comfortable | 39 |
| Comfortable | 37 |
| Average | 11 |
| Uncomfortable | 11 |
| Very uncomfortable | 2 |
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 ).
| Participants | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Preferred F&P nasal mask | 24 |
| Did not prefer F&P nasal mask | 20 |
Collected over 6 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Experimental Trial Nasal Mask | 0/45 (0%) | 0/45 (0%) | 5/45 (11.1%) |
| Event | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Sinus HeadachesRespiratory, thoracic and mediastinal disorders | 1/45 |
| Rawness on side of noseSkin and subcutaneous tissue disorders | 1/45 |
| ColdRespiratory, thoracic and mediastinal disorders | 1/45 |
| Pain in Left LegGeneral disorders | 1/45 |
| Pre-scheduled Cataract SurgerySurgical and medical procedures | 1/45 |
| Age, Customized(Participants) | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Age 22+ years | 45 |
| Sex: Female, Male(Participants) | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Female | 16 |
| Male | 29 |
| Race/Ethnicity, Customized(Participants) | Experimental: Experimental Trial Nasal Mask |
|---|---|
| Caucasian | 32 |
| Other ethnicity (Hispanic/African American/Asian/Polynesian Descent | 13 |
| Region of Enrollment(participants) | Experimental: Experimental Trial Nasal Mask |
|---|---|
| United States | 45 |
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Plan to share: No — IPD will not be shared with any other researchers or organizations.
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Fisher and Paykel Healthcare