N/A Completed N=110

Adherence Risk Indicator Validation Study

Obstructive Sleep Apnea

Source: ClinicalTrials.gov NCT02230085 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcomePrimary: CPAP Therapy Adherence — 103 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY CPAP Therapy Adherence	103	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02230085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.