N/A
Completed N=139
CPAP In-home Assessment USA
Source: ClinicalTrials.gov NCT02809859 ↗Enrolled (actual)
139
Serious AEs
1.4%
Results posted
Mar 2019
Primary outcomePrimary: Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour. — 1.9 events/hr
Summary
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour. |
1.9 | — |
| PRIMARY Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults |
— | — |
| PRIMARY Machine Reported Faults, Measured as Number of Patients With Machine Faults |
3 | — |
| PRIMARY Participant Reported Faults, Measured as Number of Participant Complaints |
9 | — |
| SECONDARY How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device |
134 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 22 and over
- Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
- For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.
Exclusion Criteria
- Contraindicated for PAP (CPAP or AutoCPAP) therapy
- Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
- Has obesity hypoventilation syndrome or congestive heart failure
- Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
- Has implanted electronic medical devices (e.g cardiac pacemakers)
- Pregnant or think they may be pregnant
- Not fluent in spoken and written English.
Data sourced from ClinicalTrials.gov (NCT02809859). 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. Informational only — not medical advice.