Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375905
• Other study ID #: SOM-014
• Status: Completed
• Phase: N/A
• Start date: December 7, 2017
• Est. completion date: April 26, 2019

Study information

• Verified date: September 2019
• Source: Sommetrics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 26, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• both parents ethnically Japanese, or one parent Japanese and the other east-Asian

• PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and <80% of apneas and hypopneas are obstructive

• cNEP collar fits and is well-tolerated

Key exclusion Criteria:

• BMI >34

• abnormalities in neck structure

• sleep disturbance other than obstructive sleep apnea

• serious medical illness

• pregnancy

Related Conditions & MeSH terms

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

Intervention

Device:
• cNEP
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas

Locations

Country	Name	City	State
United States	The Sleep Lab	Kaneohe	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Sommetrics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of sustained responders	reduction of AHI of >50% and to <15/hr from qualifying PSG	two weeks after initiation of treatment
Secondary	proportion of initial responders	reduction of AHI of >50% and to <15/hr from qualifying PSG	at PSG 1, one day
Secondary	AHI comparison with qualifying PSG	apnea-hypopnea index	one day, on three separate study occasions
Secondary	ODI comparison with qualifying PSG	oxygen desaturation index	one day, on three separate study occasions
Secondary	SpO2 <90% comparison with qualifying PSG	oxygen desaturation index <90%	one day, on three separate study occasions
Secondary	CGI of sleep	clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment	three months, and two weeks, respectively
Secondary	CGI of satisfaction with the cNEP device	clinical global impressions of the cNEP device	after two weeks of treatment
Secondary	Treatment-emergent adverse events	tabulation of treatment-emergent adverse events	two weeks