Adherence Risk Indicator Validation Study

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Administration of the questionnaire and monitoring of CPAP adherence

• Registration Number: NCT02230085
• Lead Sponsor: Fisher and Paykel Healthcare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-28
• Study Start: 2014-09
• Study First Posted: 2014-09-03
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Results First Submitted: 2016-10-11
• Results First Submitted QC: 2016-10-11
• Results First Posted: 2016-12-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CPAP therapy	Administration of the questionnaire and monitoring of CPAP adherence	-

Primary Outcome Measures

Name	Time	Method
CPAP Therapy Adherence	90 days	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.

Trial Locations

Locations (1)

EverythingCPAP; 🇺🇸 Boise, Idaho, United States