Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP

Fecha de inicio: 1 de enero de 2013

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