Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)

Study Overview
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Brief Summary
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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.

Official Title
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Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: DeVilbiss AutoAdjust CPAP with revised algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br>All subjects underwent a sleep study with DeVilbiss AutoAdjust CPAP with revised algorithm simultaneously with hand-scored PSG. | Device: DeVilbiss AutoAdjust CPAP with revised algorithm<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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. | 1 night |