DeVilbiss AutoAdjust With SmartFlex Comparative Study

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. Identifier: NCT01203956
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Information provided by (Responsible Party):
DeVilbiss Healthcare LLC

August 31, 2010
September 17, 2010
March 24, 2015
April 28, 2015
April 28, 2015
September 2010
May 2011   (Final data collection date for primary outcome measure)
Apnea-hypopnea Index (AHI) [ Time Frame: 4 weeks ]
Number of apnea/hypopnea events per hour, measured by SmartLink component of device.
The primary aim of the study will be to compare the effectiveness of the AutoAdjust with and without the SmartFlex technology in reducing AHI. [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT01203956 on Archive Site
Key Measures That Will be Used to Evaluate the Intervention(s) [ Time Frame: 2 weeks ]
The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device
Same as current
Not Provided
Not Provided
DeVilbiss AutoAdjust With SmartFlex Comparative Study
A Multi Center, Prospective, Randomized, Double Blind, Crossover Study to Compare the DeVilbiss AutoAdjust With and Without the Smartflex Device Modification; "AutoAdjust With SmartFlex Study"
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea
  • Device: SmartFlex
    Device used with smartflex engaged.
    Other Name: DeVilbiss AutoAdjust with SmartFlex
  • Device: Standard
    Other Name: DeVilbiss AutoAdjust without SmartFlex
  • Experimental: SmartFlex
    Use Continuous Airway Pressure device with SmartFlex engaged
    Intervention: Device: SmartFlex
  • Active Comparator: Standard
    Use Continuous Airway Pressure device without SmartFlex engaged
    Intervention: Device: Standard
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Epworth Sleepiness Scale >10
  • Body Mass Index > 26
  • Apnea-hypopnea index (AHI) ≥15 (mod to severe range)
  • AHI ≤ 10 at therapeutic continuous positive airway pressure (CPAP) pressure
  • CPAP naïve patients
  • Polysomnogram (PSG) within 3 months of enrollment
  • Average oxygen saturation by pulse oximetry (SpO2) > 90% during titration
  • Sleep efficiency on titration night ≥ 78%

Exclusion Criteria:

  • Diagnosis of mild obstructive sleep apnea (OSA)
  • Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (COPD) or psychiatric illness
  • Allergies to mask materials
  • Difficulties with nasal breathing
  • 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
  • Predominately central sleep apnea
  • Deemed medically unsuitable by investigator
  • Evidence of any type of infection or treatment of an infectious condition during the period of research participation
  • Full Face Mask during titration
  • Have a bi-level requirement
  • CPAP pressure >15cmH2O
  • Subjects with tracheotomy
  • Uncontrolled hypertension
  • Require supplemental oxygen
  • Stimulants, major tranquillizers or antipsychotics.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
DeVilbiss Healthcare LLC
DeVilbiss Healthcare LLC
Not Provided
Principal Investigator: Leon Rosenthal, MD Sleep Medicine Associates of Texas
DeVilbiss Healthcare LLC
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP