- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02230085
Adherence Risk Indicator Validation Study (ARI)
January 18, 2017 updated by: Fisher and Paykel Healthcare
A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally.
The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire.
The data collected from this trail allows for closer monitoring of at-risk patients.
For the study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA.
Participants will be provided with a GSM (Global System for Mobile communication) modem to allow transmission of their CPAP data.
Participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ARI prediction.
At the conclusion of the study the GSM unit is returned, and participants continue with CPAP therapy as instructed by their healthcare provider.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Idaho
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Boise, Idaho, United States, 83704
- EverythingCPAP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Any patient recieving CPAP for OSA.
Description
Inclusion Criteria:
- ≥ 18years of age
- Diagnosed with OSA (AHI >5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements
- Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years
Exclusion Criteria:
- Contraindicated for CPAP therapy
- Medically unstable condition/diagnosis that is not yet under control
- Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
- PLMA (Periodic Limb Movement Activity) Index greater than 15/hr
- Home titration of longer than 5 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CPAP therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CPAP Therapy Adherence
Time Frame: 90 days
|
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.
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
August 19, 2014
First Submitted That Met QC Criteria
August 28, 2014
First Posted (Estimate)
September 3, 2014
Study Record Updates
Last Update Posted (Actual)
March 3, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIA-121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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