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

Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: DeVilbiss AutoAdjust CPAP with revised algorithm

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • Neurocare, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; All subjects underwent a sleep study with DeVilbiss AutoAdjust CPAP with revised algorithm simultaneously with hand-scored PSG.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study	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.	1 night

Collaborators and Investigators

• Sponsor: DeVilbiss Healthcare LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 7, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: DHC-002