An interventional study of cNEP in Sleep Apnea, Obstructive, sponsored by Sommetrics, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by Sommetrics, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 71 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Sommetrics, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks
Device: cNEP
continuous negative external pressure
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
A response (either initial or sustained) is defined as an AHI that is \< 50% of the qualifying PSG (polysomnography) that is also \< 15/hr
Time frame: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
occurrence of adverse events
Adverse events that occur during the three weeks of cNEP home use.
Time frame: three weeks
"Initial Response" of AHI at PSG I
An AHI (apnea hypopnea index) that is \<50% of that of the qualifying PSG, and \<15/hr at PSG I, with cNEP in place.
Time frame: up to 12 months after the qualifying PSG
Comparison of AHI at PSG I and PSG II
The AHI determined at PSG II will be compared with that of PSG I
Time frame: three weeks
time of SpO2 (oxygen saturation) < 90%
the number of minutes during the overnight PSG when SpO2 is \< 90% with cNEP in place
Time frame: during each of the overnight PSGs
hours of home use of cNEP per night
the number of hours of each night at home that the subject uses cNEP
Time frame: three weeks after initiation of home cNEP
Three CGI (clinical global impression) subjective measures
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.
Time frame: three weeks after the initiation of home cNEP
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Sommetrics, Inc.