Adherence Risk Indicator Validation Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | November 2015 |
A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.
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.
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.
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
We found this trial at
1
site
