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OpenTrials
Completed

NCT Number: NCT06070389

Polysomnography Validation of the Sansa Device

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

Completed

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Key information

Conditions

Sleep-Disordered Breathing Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary & Sleep Specialists, Decatur, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Sansa device

Device

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

Primary outcomes

  1. Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography

    Time frame: 1 night

Sponsors and collaborators

Lead sponsor

Huxley Medical, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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