Sleep-Disordered BreathingNCT06070389
Polysomnography Validation of the Sansa Device
A study testing Sansa device in people with Sleep-Disordered Breathing, run by Huxley Medical, Inc. at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep-Disordered Breathing
- What is being tested?
- Sansa device
- Type of treatment
- Medical device
- How many people
- 533 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2023to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Pulmonary & Sleep Specialists
Decatur, Georgia, 30033
About this study
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
- Conditions
- Sleep-Disordered Breathing
- Being tested
- Sansa device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sansa deviceDevice
The Sansa device will be used during a single overnight polysomnography study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jun 2023
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huxley Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cathy Goldstein, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070389
- Sponsor's protocol ID
- EDS-50031
- Status last verified
- Aug 2024
- First submitted
- 16 Jun 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40589991
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polysomnography Validation of the Sansa Device
- ClinicalTrials.gov ID
- NCT06070389
- Acronym / sponsor ID
- EDS-50031
- Conditions
- Sleep-Disordered Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Huxley Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sansa deviceThe Sansa device will be used during a single overnight polysomnography study. | Device | – |
Primary outcome
Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography
Time frame: 1 night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 40589991Goldstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Goldstein principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sansa device in people with Sleep-Disordered Breathing, run by Huxley Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06070389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.