Adherence Risk Indicator Validation Study (ARI)

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Other: Administration of the questionnaire and monitoring of CPAP adherence

Study type: Observational

Funder types: Industry

Identifiers

NCT02230085

CIA-121

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 1 patient group

CPAP therapy

Treatment:

Other: Administration of the questionnaire and monitoring of CPAP adherence