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

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT01797705

Run by

DeVilbiss Healthcare LLC

People needed

33

Starts

2013-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-05-29

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NeuroCare, Inc. — Newton, Massachusetts, United States

Full record on ClinicalTrials.gov

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