Status:

COMPLETED

Adherence Risk Indicator Validation Study

Lead Sponsor:

Fisher and Paykel Healthcare

Conditions:

Obstructive Sleep Apnea

Eligibility:

All Genders

18+ years

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...

Eligibility Criteria

Inclusion

  • ≥ 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

  • 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

Key Trial Info

Start Date :

September 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2015

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT02230085

Start Date

September 1 2014

End Date

December 1 2015

Last Update

March 3 2017

Active Locations (1)

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EverythingCPAP

Boise, Idaho, United States, 83704