An interventional study of continuous negative external pressure in Obstructive Sleep Apnea, sponsored by Sommetrics, Inc.. Withdrawn at 1 site in United States. Open to participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by Sommetrics, Inc. · Not applicable, Interventional, and Treatment
This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
Browse Sleep Apnea, Obstructive studies →Sommetrics, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
continuous negative external pressure will be used nightly by all participants
Device: continuous negative external pressure
continuous negative external pressure will be applied to the anterior neck at night
Also known as: cNEP
Reduction in baseline apnea hypopnea index from baseline
Reduction in apnea hypopnea index (AHI) from the baseline value of \>50% and also \<15/hr
Time frame: End of Week 2 of home use
Collection of adverse events
Collection of adverse events
Time frame: two week study period
Apnea hypopnea index, as measured by home sleep testing
Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012
Time frame: two weeks
Clinical global impression of cNEP experience
Assessment of the tolerability of cNEP to the subject via a clinical global impression scale
Time frame: end of week two of home use
Bed partner's views of cNEP via a clinical global impression scale
Determination of the bed partner's views of the subject using cNEP in the home setting using a clinical global impression scale
Time frame: end of two weeks of home use
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2017; primary completion for Jun 2018, 8 months later.
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This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Sommetrics, Inc.