Adherence Risk Indicator Validation Study

Completed

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT02230085

Run by

Fisher and Paykel Healthcare

People needed

110

Starts

2014-09-01

Expected to finish

2015-12-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• EverythingCPAP — Boise, Idaho, United States

Full record on ClinicalTrials.gov

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