Adherence Risk Indicator Validation Study

Overview

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.

Full Title of Study: “A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2015

Interventions

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

Arms, Groups and Cohorts

  • CPAP therapy

Clinical Trial Outcome Measures

Primary Measures

  • CPAP Therapy Adherence
    • Time Frame: 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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fisher and Paykel Healthcare
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.