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

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Key information

Conditions

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

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NeuroCare, Inc.

Newton, Massachusetts, 02459, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study

Time frame: 1 night

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.

Sponsors and collaborators

Lead sponsor

DeVilbiss Healthcare LLC

Industry

Registry information

Official study title

Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Feb 22, 2013
Registry last updated: May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed