Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatment administration of the questionnaire and monitoring of cpap adherence
Sponsor Fisher and Paykel Healthcare
Start date September 2014
End date August 2015
Trial size 110 participants
Trial identifier NCT02230085, CIA-121

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
administration of the questionnaire and monitoring of cpap adherence

Primary Outcomes

Measure
CPAP therapy adherence
time frame: 90 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Fisher and Paykel Healthcare.