Adherence Risk Indicator Validation Study

Fisher and Paykel Healthcare110 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

110

Conditions

Obstructive Sleep Apnea

Interventions

Administration of the questionnaire and monitoring of CPAP adherenceOTHER

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

CPAP Therapy Adherence

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