Polysomnography Validation of the Sansa Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

533 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-13

Brief Summary

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The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.

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Detailed Description

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Conditions

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Sleep-Disordered Breathing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Sansa device

The Sansa device will be used during a single overnight polysomnography study.

Intervention Type DEVICE

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes