DeVilbiss AutoAdjust With SmartFlex Comparative Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DeVilbiss Healthcare LLC
ClinicalTrials.gov Identifier:
NCT01203956
First received: August 31, 2010
Last updated: February 10, 2014
Last verified: February 2014

August 31, 2010
February 10, 2014
September 2010
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01203956 on ClinicalTrials.gov Archive Site
Key measures that will be used to evaluate the intervention(s) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea
Device: Positive Airway Pressure
A crossover study with and without smartflex engaged, each period lasting for two weeks.
Other Name: DeVilbiss AutoAdjust with SmartFlex
Experimental: Auto Adjust/SmartFlex
Intervention: Device: Positive Airway Pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Epworth Sleepiness Scale >10
  • Body Mass Index > 26
  • AHI≥15 (mod to severe range)
  • AHI ≤ 10 at therapeutic CPAP pressure
  • CPAP naïve patients
  • PSG within 3 months of enrollment
  • Average SpO2 > 90% during titration
  • Sleep efficiency on titration night ≥ 78%

Exclusion Criteria:

  • Diagnosis of mild OSA
  • Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203956
DHC-C001
No
DeVilbiss Healthcare LLC
DeVilbiss Healthcare LLC
Not Provided
Principal Investigator: Leon Rosenthal, MD Sleep Medicine Associates of Texas
DeVilbiss Healthcare LLC
February 2014

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