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Clinical Trials/NCT03375905
NCT03375905CompletedNot Applicable

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

Sommetrics, Inc.2 sites in 1 country8 target enrollmentStarted: December 7, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
8
Locations
2
Primary Endpoint
proportion of sustained responders
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • •abnormalities in neck structure
  • •sleep disturbance other than obstructive sleep apnea
  • •serious medical illness
  • •pregnancy

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

proportion of sustained responders

Time Frame: two weeks after initiation of treatment

reduction of AHI of \>50% and to \<15/hr from qualifying PSG

Secondary Outcomes

  • proportion of initial responders(at PSG 1, one day)
  • CGI of satisfaction with the cNEP device(after two weeks of treatment)
  • ODI comparison with qualifying PSG(one day, on three separate study occasions)
  • AHI comparison with qualifying PSG(one day, on three separate study occasions)
  • SpO2 <90% comparison with qualifying PSG(one day, on three separate study occasions)
  • CGI of sleep(three months, and two weeks, respectively)
  • Treatment-emergent adverse events(two weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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Effectiveness and Safety of cNEP in Ethnic... | Clinical Trial