Obstructive Sleep Apnea
Conditions
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 (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.
Interventions
OTHERAdministration of the questionnaire and monitoring of CPAP adherence
Sponsors
Fisher and Paykel Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP Therapy Adherence | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CPAP Therapy Administration of the questionnaire and monitoring of CPAP adherence | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | CPAP Therapy |
|---|---|
| Age, Continuous | 51 years |
| Region of Enrollment United States | 103 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 110 |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
CPAP Therapy Adherence
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.
Time frame: 90 days
Population: 103 patients CPAP therapy adherence data was collected. 3 patients data was either lost or unable to be downloaded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP Therapy | CPAP Therapy Adherence | 103 participants |