Polysomnography Validation of the Sansa Device | NCT06070389

Studies
Polysomnography Validation of the Sansa Device

NCT06070389

Sponsor

Huxley Medical, Inc.

Status

Completed

Last Update Posted

Aug 14, 2024Actual

Enrollment

533Actual

Phase

Not Applicable

Conditions

Sleep-Disordered Breathing

Interventions

Sansa device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Dec 13, 2023Actual

Completion Date

Dec 13, 2023Actual

First Submitted Date

Jun 16, 2023

First Submission Date that Met QC Criteria

Oct 4, 2023

First Posted Date

Oct 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

533Actual

Name	Type	Description	Arm Group Labels	Other Names
Sansa device	Device	The Sansa device will be used during a single overnight polysomnography study.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cathy Goldstein	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary & Sleep Specialists		Decatur	Georgia	30033	United States
University of Michigan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40589991	Derived	Goldstein C, Ghanbari H, Sharma S, Collop N, Namen A, Kirsch DB, Drucker M, Khayat R, Pollock M, Torstrick B, Walsh C, Herreshoff E, Frankel DS, Rosen IM. Polysomnography validation of SANSA to detect obstructive sleep apnea. Front Neurol. 2025 Jun 16;16:1592690. doi: 10.3389/fneur.2025.1592690. eCollection 2025.

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic