Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial

Obstructive Sleep Apnea Clinical Trial

Official title:

Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be "Responders"

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03108417
• Other study ID #: SOM-013
• Status: Withdrawn
• Phase: N/A
• First received: March 25, 2017
• Last updated: November 15, 2017
• Start date: October 2017
• Est. completion date: September 2018

Study information

• Verified date: November 2017
• Source: Sommetrics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

Inclusion Criteria:

• must have completed study SOM-012 and been categorized as a "responder"

• the subject agrees to participation by signing an informed consent statement

Exclusion Criteria:

• medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• continuous negative external pressure
continuous negative external pressure will be applied to the anterior neck at night

Locations

Country	Name	City	State
United States	California Center for Sleep Disorders	Alameda	California

Sponsors (1)

Lead Sponsor	Collaborator
Sommetrics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical global impression of cNEP experience	Assessment of the tolerability of cNEP to the subject via a clinical global impression scale	end of week two of home use
Other	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	end of two weeks of home use
Primary	Reduction in baseline apnea hypopnea index from baseline	Reduction in apnea hypopnea index (AHI) from the baseline value of >50% and also <15/hr	End of Week 2 of home use
Secondary	Collection of adverse events	Collection of adverse events	two week study period
Secondary	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	two weeks