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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
All subjects	DeVilbiss AutoAdjust CPAP with revised algorithm	All subjects underwent a sleep study with DeVilbiss AutoAdjust CPAP with revised algorithm simultaneously with hand-scored PSG.

Primary Outcome Measures

Name	Time	Method
% 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.

Secondary Outcome Measures