Obstructive Sleep Apnea
Conditions
Keywords
OSA, Sleep Apnea, PAP, positive airway pressure
Brief summary
The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and respiratory events.
Detailed description
Acclimate has been designed as a comfort feature for patients starting PAP therapy. The feature allows acclimatization to the targeted positive airway pressure setting. Using the Acclimate feature, the pressure increases incrementally over a period of time. The feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.
Interventions
DEVICES9 Elite with Acclimate
S9 Elite Flow Generator with Acclimate feature activated
DEVICES9 Elite
S9 Elite Flow Generator
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects ≥18 years of age. * Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated. * Naïve to PAP therapy.
Exclusion criteria
* Patients requiring supplemental oxygen. * Patients with a history of pneumothorax, pneumomediastinum, cavities or cysts in the lung. * Previous surgery to the brain, middle or inner ear, pituitary gland or sinuses. * Middle ear infection or perforated ear drum. * Ongoing sinus infection/sinusitis. * Clinically significant epistaxis. * Predominant central sleep apneas in the subject's PSG.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hours Used | 30 days | The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at one (1) clinical site in the US. The first subject was consented 06Sept2011 (Subject 01) and the last subject consented on 23Nov2011 (Subject 23).
Participants by arm
| Arm | Count |
|---|---|
| Fixed Mode + Acclimate S9 Elite flow generator with Acclimate feature activated. | 11 |
| Fixed Mode Only S9 Elite Flow Generator with Fixed Mode only | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Fixed Mode Only | Fixed Mode + Acclimate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 10 Participants | 16 Participants |
| Age Continuous | 58.5 years STANDARD_DEVIATION 9.2 | 52.3 years STANDARD_DEVIATION 11.2 | 55.1 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 9 participants | 11 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Primary
Hours Used
The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed Mode + Acclimate | Hours Used | 146.9 Total Hours Used | Standard Deviation 62.9 |
| Fixed Mode Only | Hours Used | 141.9 Total Hours Used | Standard Deviation 64.8 |