DeVilbiss AutoAdjust With SmartFlex Comparative Study

This study has been completed.
Information provided by (Responsible Party):
DeVilbiss Healthcare LLC Identifier:
First received: August 31, 2010
Last updated: April 8, 2015
Last verified: April 2015
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.

Condition Intervention
Obstructive Sleep Apnea
Device: SmartFlex
Device: Standard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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"

Further study details as provided by DeVilbiss Healthcare LLC:

Primary Outcome Measures:
  • Apnea-hypopnea Index (AHI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of apnea/hypopnea events per hour, measured by SmartLink component of device.

Secondary Outcome Measures:
  • 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

Enrollment: 28
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SmartFlex
Use Continuous Airway Pressure device with SmartFlex engaged
Device: SmartFlex
Device used with smartflex engaged.
Other Name: DeVilbiss AutoAdjust with SmartFlex
Active Comparator: Standard
Use Continuous Airway Pressure device without SmartFlex engaged
Device: Standard
Other Name: DeVilbiss AutoAdjust without SmartFlex


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01203956

United States, Texas
Sleep Medicine Associates of Texas
Dallas, Texas, United States, 75231
Sleep Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
DeVilbiss Healthcare LLC
Principal Investigator: Leon Rosenthal, MD Sleep Medicine Associates of Texas
  More Information

No publications provided

Responsible Party: DeVilbiss Healthcare LLC Identifier: NCT01203956     History of Changes
Other Study ID Numbers: DHC-C001
Study First Received: August 31, 2010
Results First Received: March 24, 2015
Last Updated: April 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by DeVilbiss Healthcare LLC:
Apnea Hypopnea Index
Patient reported outcomes

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Apnea Syndromes
Sleep Disorders
Sleep Disorders, Intrinsic processed this record on November 27, 2015