N/A
N=49
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
Obstructive Sleep Apnea (OSA)
Bottom Line
View on ClinicalTrials.gov: NCT02214238 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: PAP Treatment Efficacy — 4.2; 4.0 Events per hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PAP device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fisher and Paykel Healthcare
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PAP Treatment Efficacy |
4.2; 4.0 | — |
| SECONDARY PAP Treatment Comfort |
5; 5 | — |
| SECONDARY PAP Compliance |
438; 430 | — |
Summary
This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance. Patients will have their treatment pressure titrated using polysomnography (PSG) in the sleep laboratory, and then in a random order will spend additional time undergoing PSG using both devices, and using both devices at home for 3 weeks. Data will be collected from the PSG studies, device downloads, independent pressure-flow loggers, and custom questionnaires.
Eligibility Criteria
Inclusion Criteria
- Aged 18+
- Diagnosed with OSA by a practicing sleep physician
Exclusion Criteria
- Patients with a known history of Cerebrospinal fluid leak, abnormalities of the cribriform plate, head trauma and/or pneumocephalus
- Patients with pathologically low blood pressure, pneumothorax, a previous history of pneumothorax, or dehydration.
- Patient with bypassed upper airway
- Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea)
- Previous use of a bi-level device with-in the last 2 years (from enrolment date).
- Patients with respiratory failure, bullous lung disease or COPD (Chronic Obstructive Pulmonary Disease).
- Patients with obesity hypoventilation syndrome or congestive heart failure
- Patients that require supplemental oxygen with their CPAP (Continuous Positive Airway Pressure) device
- Patients with implanted or life-supporting electronic medical devices (e.g. cardiac pacemakers)
Data sourced from ClinicalTrials.gov (NCT02214238). 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.