Polysomnography Validation of the Sansa Device
1 other identifier
interventional
533
1 country
2
Brief Summary
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2023
CompletedAugust 14, 2024
August 1, 2024
7 months
June 16, 2023
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography
1 night
Interventions
The Sansa device will be used during a single overnight polysomnography study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pulmonary & Sleep Specialists
Decatur, Georgia, 30033, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
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.
PMID: 40589991DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cathy Goldstein
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2023
First Posted
October 6, 2023
Study Start
June 1, 2023
Primary Completion
December 13, 2023
Study Completion
December 13, 2023
Last Updated
August 14, 2024
Record last verified: 2024-08