NCT02230085

Adherence Risk Indicator Validation Study

A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
OTHER	Administration of the questionnaire and monitoring of CPAP adherence

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2014-09-03
• Last updated: 2017-03-03
• Results posted: 2016-12-02

Locations

1 site across 1 country: United States