Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

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: NCT01405313
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):

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

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
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

  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.
All 21 patients completed the cross over study design

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

Baseline Measures
   Modified ASV/Conventional ASV 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      4  19.0% 
>=65 years      17  81.0% 
[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

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

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

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

Publications of Results:
Other Publications:

Responsible Party: ResMed Identifier: NCT01405313     History of Changes
Other Study ID Numbers: MA231210
First Submitted: July 21, 2011
First Posted: July 29, 2011
Results First Submitted: September 20, 2012
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017