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

Brief Summary:
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: SmartFlex Device: Standard Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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"
Study Start Date : September 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Apnea-hypopnea Index (AHI) [ Time Frame: 4 weeks ]
    Number of apnea/hypopnea events per hour, measured by SmartLink component of device.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): 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

Responsible Party: DeVilbiss Healthcare LLC Identifier: NCT01203956     History of Changes
Other Study ID Numbers: DHC-C001
First Posted: September 17, 2010    Key Record Dates
Results First Posted: April 28, 2015
Last Update Posted: April 28, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases