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: April 8, 2015
Last verified: April 2015
Results First Received: March 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Interventions: Device: SmartFlex
Device: Standard

  Participant Flow
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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
  Description
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]
NOT COMPLETED     0     0  
[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]
NOT COMPLETED     5     6  
Non-compliant: no evaluable results                 5                 6  
[1] Completed with evaluable results, as assessed over both two-week study periods.



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

Baseline Measures
    All Evaluable Subjects  
Number of Participants  
[units: participants]
  17  
Age  
[units: years]
Mean (Standard Deviation)
  48.4  (9.9)  
Gender  
[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.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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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
e-mail: LRosenthal@sleepmed.com


No publications provided


Responsible Party: DeVilbiss Healthcare LLC
ClinicalTrials.gov 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