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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Interventions: Device: SmartFlex
Device: Standard

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
SmartFlex First, Then Standard First two weeks with Smartflex engaged, second two weeks without Smartflex engaged
Standard First, Then Smartflex First two weeks without Smartflex engaged, second two weeks with Smartflex engaged

Participant Flow for 2 periods

Period 1:   First Two-week Period
    SmartFlex First, Then Standard   Standard First, Then Smartflex
STARTED   15   13 
COMPLETED   15 [1]   13 [1] 
[1] All participants continued to the second two-week period, whether or not they had evaluable results.

Period 2:   Second Two-week Period
    SmartFlex First, Then Standard   Standard First, Then Smartflex
STARTED   15   13 
Attended Sleep Studies for 14 Nights   15   13 
COMPLETED   10 [1]   7 [1] 
Non-compliant: no evaluable results                5                6 
[1] Completed with evaluable results, as assessed over both two-week study periods.

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Compliant participants completing study with evaluable results

Reporting Groups
All Evaluable Subjects All subjects completing both two-week periods of crossover study, with evaluable results for each period.

Baseline Measures
   All Evaluable Subjects 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 48.4  (9.9) 
[Units: Participants]
Female   7 
Male   10 
AHI (apnea-hypopnea index) 
[Units: Events / hour]
Mean (Standard Deviation)
 39.8  (21.5) 

  Outcome Measures

1.  Primary:   Apnea-hypopnea Index (AHI)   [ Time Frame: 4 weeks ]

2.  Secondary:   Key Measures That Will be Used to Evaluate the Intervention(s)   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Leon Rosenthal, MD
Organization: Sleep Medicine Associates of Texas
phone: 214-750-7776

Responsible Party: DeVilbiss Healthcare LLC Identifier: NCT01203956     History of Changes
Other Study ID Numbers: DHC-C001
First Submitted: August 31, 2010
First Posted: September 17, 2010
Results First Submitted: March 24, 2015
Results First Posted: April 28, 2015
Last Update Posted: April 28, 2015