An interventional study of cNEP in Obstructive Sleep Apnea, sponsored by Sommetrics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Sommetrics, Inc. · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 8 is below 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.
Inclusion Criteria:
Key exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cNEP treatment
Device: cNEP
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
Also known as: continuous negative external pressure
proportion of sustained responders
reduction of AHI of \>50% and to \<15/hr from qualifying PSG
Time frame: two weeks after initiation of treatment
proportion of initial responders
reduction of AHI of \>50% and to \<15/hr from qualifying PSG
Time frame: at PSG 1, one day
AHI comparison with qualifying PSG
apnea-hypopnea index
Time frame: one day, on three separate study occasions
ODI comparison with qualifying PSG
oxygen desaturation index
Time frame: one day, on three separate study occasions
SpO2 <90% comparison with qualifying PSG
oxygen desaturation index \<90%
Time frame: one day, on three separate study occasions
CGI of sleep
clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment
Time frame: three months, and two weeks, respectively
CGI of satisfaction with the cNEP device
clinical global impressions of the cNEP device
Time frame: after two weeks of treatment
Treatment-emergent adverse events
tabulation of treatment-emergent adverse events
Time frame: two weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Mar 2019, 15 months.
Of 115 industry-sponsored interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 15 months is above that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Sommetrics, Inc.