Sleep Apnea, Obstructive
Conditions
Keywords
obstructive sleep apnea, sleep apnea, OSA, cNEP, continuous negative external pressure
Brief summary
The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea
Interventions
DEVICEcNEP
continuous negative external pressure
Sponsors
Sommetrics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the qualifying PSG) * on that PSG, AHI must be 10 - 50/hr and \>80% of the apneas and hypopneas must be obstructive * no significant changes in health, medications, or lifestyle since the qualifying PSG Key
Exclusion criteria
* previous major surgery, injury or radiation to the neck * beard or excessive hair on the area of the neck where the collar will be applied * carotid artery disease * serious medical conditions * pregnancy * use of home oxygen * silicone allergy * sleep disturbance other than obstructive sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Response of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II | three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I | A response (either initial or sustained) is defined as an AHI that is \< 50% of the qualifying PSG (polysomnography) that is also \< 15/hr |
| occurrence of adverse events | three weeks | Adverse events that occur during the three weeks of cNEP home use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time of SpO2 (oxygen saturation) < 90% | during each of the overnight PSGs | the number of minutes during the overnight PSG when SpO2 is \< 90% with cNEP in place |
| Initial Response of AHI at PSG I | up to 12 months after the qualifying PSG | An AHI (apnea hypopnea index) that is \<50% of that of the qualifying PSG, and \<15/hr at PSG I, with cNEP in place. |
| Three CGI (clinical global impression) subjective measures | three weeks after the initiation of home cNEP | Seven-item Likert CGI scales of three subjective measures: 1) subject's view of cNEP vs CPAP, 2) overall satisfaction with cNEP, 3) bed partner's feelings about cNEP. |
| hours of home use of cNEP per night | three weeks after initiation of home cNEP | the number of hours of each night at home that the subject uses cNEP |
| Comparison of AHI at PSG I and PSG II | three weeks | The AHI determined at PSG II will be compared with that of PSG I |
Countries
Canada
Outcome results
None listed