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Adherence Risk Indicator Validation Study (ARI)

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.
ClinicalTrials.gov Identifier: NCT02230085
Recruitment Status : Completed
First Posted : September 3, 2014
Results First Posted : December 2, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Obstructive Sleep Apnea
Intervention Other: Administration of the questionnaire and monitoring of CPAP adherence
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CPAP Therapy
Hide Arm/Group Description Administration of the questionnaire and monitoring of CPAP adherence
Period Title: Overall Study
Started 110
Completed 106
Not Completed 4
Reason Not Completed
Physician Decision             1
Withdrawal by Subject             3
Arm/Group Title CPAP Therapy
Hide Arm/Group Description Administration of the questionnaire and monitoring of CPAP adherence
Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 103 participants
51
(27 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
43
  41.7%
Male
60
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 103 participants
103
1.Primary Outcome
Title CPAP Therapy Adherence
Hide Description Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
103 patients CPAP therapy adherence data was collected. 3 patients data was either lost or unable to be downloaded.
Arm/Group Title CPAP Therapy
Hide Arm/Group Description:
Administration of the questionnaire and monitoring of CPAP adherence
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
103
Time Frame Adverse event data was collected over 90 days for each participant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CPAP Therapy
Hide Arm/Group Description Administration of the questionnaire and monitoring of CPAP adherence
All-Cause Mortality
CPAP Therapy
Affected / at Risk (%)
Total   0/110 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CPAP Therapy
Affected / at Risk (%)
Total   0/110 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CPAP Therapy
Affected / at Risk (%)
Total   0/110 (0.00%) 
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 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 an undescribed period .
Results Point of Contact
Name/Title: Clinical Research Scientist
Organization: Fisher & Paykel Healthcare
Phone: +6495740123
Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02230085     History of Changes
Other Study ID Numbers: CIA-121
First Submitted: August 19, 2014
First Posted: September 3, 2014
Results First Submitted: October 11, 2016
Results First Posted: December 2, 2016
Last Update Posted: March 3, 2017