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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01797705
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : April 28, 2015
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
DeVilbiss Healthcare LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: DeVilbiss AutoAdjust CPAP with revised algorithm Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. % 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797705


Locations
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United States, Massachusetts
NeuroCare, Inc.
Newton, Massachusetts, United States, 02459
Sponsors and Collaborators
DeVilbiss Healthcare LLC
More Information
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Responsible Party: DeVilbiss Healthcare LLC
ClinicalTrials.gov Identifier: NCT01797705    
Other Study ID Numbers: DHC-002
First Posted: February 22, 2013    Key Record Dates
Results First Posted: April 28, 2015
Last Update Posted: May 29, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases