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Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421654
First Posted: August 23, 2011
Last Update Posted: March 12, 2013
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.
Information provided by (Responsible Party):
ResMed
Results First Submitted: January 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Interventions: Device: S9 Elite with Acclimate
Device: S9 Elite

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at one (1) clinical site in the US. The first subject was consented 06Sept2011 (Subject 01) and the last subject consented on 23Nov2011 (Subject 23).

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
Fixed Mode + Acclimate S9 Elite flow generator with Acclimate feature activated.
Fixed Mode Only S9 Elite Flow Generator with Fixed Mode only

Participant Flow:   Overall Study
    Fixed Mode + Acclimate   Fixed Mode Only
STARTED   11   9 
COMPLETED   11   9 [1] 
NOT COMPLETED   0   0 
[1] 10 subjects completed study, but 1 subject was found to not meet IEC at the end; data was not used.



  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.
No text entered.

Reporting Groups
  Description
Fixed Mode + Acclimate S9 Elite flow generator with Acclimate feature activated.
Fixed Mode Only S9 Elite Flow Generator with Fixed Mode only
Total Total of all reporting groups

Baseline Measures
   Fixed Mode + Acclimate   Fixed Mode Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   9   20 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   6   16 
>=65 years   1   3   4 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.3  (11.2)   58.5  (9.2)   55.1  (10.1) 
Gender 
[Units: Participants]
     
Female   5   4   9 
Male   6   5   11 
Region of Enrollment 
[Units: Participants]
     
United States   11   9   20 


  Outcome Measures

1.  Primary:   Hours Used   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Amy Blase/Clinical Research Manager
Organization: ResMed
phone: 858-836-6715
e-mail: amy.blase@resmed.com



Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01421654     History of Changes
Other Study ID Numbers: MA-03-11-01
First Submitted: August 19, 2011
First Posted: August 23, 2011
Results First Submitted: January 31, 2013
Results First Posted: March 7, 2013
Last Update Posted: March 12, 2013