Polysomnography Validation of the Sansa Device

August 12, 2024 updated by: Huxley Medical, Inc.
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

533

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Pulmonary & Sleep Specialists
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older
  • able to read, understand, and sign informed consent documentation
  • willing to sleep with the Sansa device and PSG simultaneously in the sleep clinic
  • suspected or known to have sleep disordered breathing

Exclusion Criteria:

  • exhibit deformities of the chest that would interfere with sensor placement
  • have broken or injured skin that would interfere with sensor placement
  • known to experience adverse reactions to medical-grade adhesive
  • diagnosed with hypoventilation
  • diagnosed with severe chronic obstructive pulmonary disease
  • exhibit symptoms of significant non-respiratory sleep disorders
  • diagnosed with a neuromuscular disorder leading to muscle weakness
  • chronically use supplemental oxygen at night or during the day
  • pregnant
  • scheduled to undergo titration of a hypoglossal nerve stimulation device
  • undergo permanent pacing with an implanted pacemaker
  • diagnosed with congestive heart failure with an ejection fraction less than 45%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography
Time Frame: 1 night
1 night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huxley Medical, Inc.

Investigators

  • Principal Investigator: Cathy Goldstein, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

December 13, 2023

Study Completion (Actual)

December 13, 2023

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDS-50031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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