CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Administration of the questionnaire and monitoring of CPAP adherenceother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02230085
NCT02230085N/ACompleted

A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.

Fisher and Paykel Healthcare·observational·Posted Sep 3, 2014·Updated Mar 3, 2017

In Brief

An observational study evaluating Administration of the questionnaire and monitoring of CPAP adherence for Obstructive Sleep Apnea. Completed, enrolled 110 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 3, 2014
Enrollment StartSep 1, 2014
Primary CompletionAug 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.8 years ago

Interventions

Administration of the questionnaire and monitoring of CPAP adherenceother