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

Adherence Risk Indicator Validation Study

Sponsors

Lead sponsor: Fisher and Paykel Healthcare

Source 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.

Overall Status Completed
Start Date September 2014
Completion Date December 2015
Primary Completion Date August 2015
Study Type Observational
Primary Outcome
Measure Time Frame
CPAP Therapy Adherence 90 days
Enrollment 110
Condition
Intervention

Intervention type: Other

Intervention name: Administration of the questionnaire and monitoring of CPAP adherence

Arm group label: CPAP therapy

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
EverythingCPAP
Location Countries

United States

Verification Date

January 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: CPAP therapy

Acronym ARI
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov