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

NCT01797705 | Completed Results

• 1 other identifier: DHC-002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (1)

All subjects

EXPERIMENTAL

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

Interventions

DeVilbiss AutoAdjust CPAP with revised algorithm 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.

All subjects

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• DeVilbiss Healthcare LLC: lead

Study Sites (1)

NeuroCare, Inc.

Newton, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Jim Froehlich
• Organization: DeVilbiss Healthcare

Jim.Froehlich@devilbisshc.com

814-443-7692

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: February 22, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 29, 2015
• Results First Posted: April 28, 2015

Record last verified: 2015-05

Locations

US (1)