N/A
N=35
The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT03294629 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Compliance of Auto-CPAP Therapy — 41.8; 39.7 percentage of nights
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SensAwake™ modification (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance of Auto-CPAP Therapy |
41.8; 39.7 | — |
| SECONDARY Average SA Detections |
2.1; 0 | — |
| SECONDARY Average Pressures of Auto-CPAP Machine |
6.9; 7.3 | — |
| SECONDARY 90th Percentile Pressures of Auto-CPAP Machine |
8.6; 9.2 | — |
| SECONDARY Average Leaks of Auto-CPAP Machine |
41.3; 44.6 | — |
| SECONDARY 90th Percentile Leaks of Auto-CPAP Machine |
57.6; 58.9 | — |
| SECONDARY Residual Apnea-Hypopnea Index (AHI) |
6.3; 5.0 | — |
| SECONDARY Time Used of Auto-CPAP Machine |
213.1; 206.8 | — |
| SECONDARY Percentage of Day Used of Auto-CPAP Machine |
87.1; 88.1 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
8.0; 8.0 | — |
| SECONDARY Epworth Sleepiness Score (ESS) |
11.1; 12.1 | — |
| SECONDARY Nasal Obstruction Symptom Evaluation (NOSE) |
14.6; 13.3 | — |
Summary
This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial with crossover design, comparing compliance on standard APAP with compliance using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.
Eligibility Criteria
Inclusion Criteria
- Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.
Exclusion Criteria
- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
- Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
- Any known factor that result in mask taken of such as skin discomfort, nasal obstruction, water dripping inside the tubing system etc.
Data sourced from ClinicalTrials.gov (NCT03294629). 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.