Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.
Interventions
DEVICEDeVilbiss AutoAdjust CPAP with revised algorithm
Subjects attended a one-night polysomnogram (PSG) titration study. DeVilbiss AutoAdjust CPAP with a revised algorithm was compared to hand-scored PSG to determine whether the machine results were equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure.
Sponsors
DeVilbiss Healthcare LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Apnea hypopnea index ≥ 15 / hour of sleep on the diagnostic polysomnogram, or diagnostic component of a split night polysomnogram * Sleep efficiency reported on CPAP titration night PSG should be \> 78% * Diagnosis of moderate to severe obstructive sleep apnea (AHI ≥15) or central/complex sleep apnea * On stable CPAP or APAP \[Automatic Positive Airway Pressure\] therapy, with compliant use averaging 4 or more hours nightly * Age 21-75 years * Predominately central sleep apnea for up to 10 subjects only * Willingness to give written informed consent and ability to adhere to visit schedule
Exclusion criteria
Diagnosis of mild sleep apnea * CPAP naïve patients * Co-morbid conditions which render participation to be at risk. These may include patients with congestive heart failure, COPD \[Chronic Obstructive Pulmonary Disease\] or psychiatric illness * Allergies to mask materials * Evidence of another primary sleep disorder * Evidence of arousing periodic limb movements during titration * Contraindications as listed on product labeling * Pregnant * Currently diagnosed with depression if symptomatic * Deemed medically unsuitable by investigator * Evidence of any type of infection or treatment of an infectious condition during the period of research participation * Have a bi-level requirement, or prescribed a bi-level therapy device * CPAP pressure \>15cmH2O * Subjects with tracheotomy * Uncontrolled hypertension * Require supplemental oxygen * Stimulants, major tranquillizers or antipsychotics * Restless Leg Syndrome or Periodic Leg Movement Index of \> 5 per hour
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Agreement Between Reviewer and Machine Pressure Settings During Sleep Study | 1 night | The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an agree or disagree. Pressure changes might show no change, increase or decrease during the 20-minute epoch. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Evaluable Subjects All subjects completing the one-night sleep study with evaluable results. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment anomalies during sleep studies | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Evaluable Subjects |
|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 13.1 |
| Apnea Type at Enrollment Central Sleep Apnea | 2 participants |
| Apnea Type at Enrollment Obstructive Sleep Apnea | 26 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study
The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an agree or disagree. Pressure changes might show no change, increase or decrease during the 20-minute epoch.
Time frame: 1 night
Population: Subjects completing the study with evaluable results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Evaluable Subjects | % Agreement Between Reviewer and Machine Pressure Settings During Sleep Study | 92.2 percentage of agreement |