N/A
N=110
Adherence Risk Indicator Validation Study
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02230085 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: CPAP Therapy Adherence — 103 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Administration of the questionnaire and monitoring of CPAP adherence (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fisher and Paykel Healthcare
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CPAP Therapy Adherence |
103 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02230085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.