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

NCT ID: NCT01797705

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-05-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All subjects

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

Group Type: EXPERIMENTAL

DeVilbiss AutoAdjust CPAP with revised algorithm

Intervention Type: DEVICE

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.

Interventions

DeVilbiss AutoAdjust CPAP with revised algorithm

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DeVilbiss Healthcare LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NeuroCare, Inc.

Newton, Massachusetts, United States

Countries

United States

Other Identifiers

DHC-002

Identifier Type: -

Identifier Source: org_study_id