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Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01405313
First received: July 21, 2011
Last updated: January 30, 2017
Last verified: September 2012
Results First Received: September 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Periodic Breathing
Breathing-Related Sleep Disorder
Interventions: Device: Modified Adaptive Servoventilation Device
Device: Conventional Adaptive Servoventilation device

  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
Clinic population already established on ASV therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants continued through to group assignment.

Reporting Groups
  Description
First Modified ASV Then Conventional ASV Patients receive Modified ASV algorithm as therapy for 1 night, then Conventional ASV for 1 night

Participant Flow:   Overall Study
    First Modified ASV Then Conventional ASV
STARTED   21 
COMPLETED   21 
NOT COMPLETED   0 



  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.
All 21 patients completed the cross over study design

Reporting Groups
  Description
Modified ASV/Conventional ASV Therapy used was Modified ASV and then Conventional ASV

Baseline Measures
   Modified ASV/Conventional ASV 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4  19.0% 
>=65 years      17  81.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.9  (8.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2   9.5% 
Male      19  90.5% 
Region of Enrollment 
[Units: Participants]
 
Germany   21 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Apnea/Hypopnea Index (AHI)   [ Time Frame: One night ]

2.  Secondary:   Oxygen Desaturation Index (ODI)   [ Time Frame: One night ]


  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
None to report


  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: Director Medical Affairs
Organization: ResMed
phone: +6128841000
e-mail: adamb@resmed.com.au


Publications of Results:
Other Publications:

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01405313     History of Changes
Other Study ID Numbers: MA231210
Study First Received: July 21, 2011
Results First Received: September 20, 2012
Last Updated: January 30, 2017