search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DeVilbiss AutoAdjust CPAP with revised algorithm
Sponsored by
DeVilbiss Healthcare LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • NeuroCare, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

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

Outcomes

Primary Outcome Measures

% 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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2013
Last Updated
May 7, 2015
Sponsor
DeVilbiss Healthcare LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01797705
Brief Title
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
Official Title
Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DeVilbiss Healthcare LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
All subjects underwent a sleep study with DeVilbiss AutoAdjust CPAP with revised algorithm simultaneously with hand-scored PSG.
Intervention Type
Device
Intervention Name(s)
DeVilbiss AutoAdjust CPAP with revised algorithm
Intervention Description
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 Outcome Measure Information:
Title
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study
Description
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.
Time Frame
1 night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
NeuroCare, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs