Polysomnography Validation of the Sansa Device

Huxley Medical, Inc.

Status: Completed

Conditions: Sleep-Disordered Breathing

Treatments: Device: Sansa device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06070389

EDS-50031

Details and patient eligibility

About

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

Enrollment: 533 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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%

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)