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NCT02230085 Clinical Trial

Adherence Risk Indicator Validation Study

Obstructive Sleep Apnea Clinical Trial

— ARI  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02230085
Other study ID # CIA-121
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 19, 2014
Last updated August 19, 2015
Start date September 2014
Est. completion date November 2015

Study information
Verified date August 2015
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 110
Est. completion date November 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Administration of the questionnaire and monitoring of CPAP adherence

Locations
Country Name City State
United States EverythingCPAP Boise Idaho

Sponsors (1)
Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary CPAP therapy adherence 90 days No
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