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

DeVilbiss Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: DeVilbiss AutoAdjust CPAP with revised algorithm

Study type: Interventional

Funder types: Industry

Identifiers

NCT01797705

DHC-002

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

All subjects

Experimental group

Description:

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

Treatment:

Device: DeVilbiss AutoAdjust CPAP with revised algorithm