Sleep Disorder (Disorder)NCT06881667
US Development and Evaluation Study of a Patch-Based PSG System
A study testing Home PSG Assessment in people with Sleep Disorder (Disorder), run by Onera BV at 2 sites in United States.
Trial summary
The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder (Disorder)
- What is being tested?
- Home PSG Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2023to 2 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Referral for a suspected sleep disorder requiring a sleep diagnostic study
Who cannot join
- Inability to provide informed consent
- History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
- Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
- Has an implanted cardiac stimulator or diaphragmatic pacer
- Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
- Will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs, external cardiac stimulators during their use of the Onera device
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Clayton Sleep Institute
St Louis, Missouri, 63123
About this study
The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.
Read the detailed description
The diagnostic gold standard to detect a sleep disorder in the presence of a comorbidity is attended, inpatient, polysomnography (PSG)1. Currently, these tests are limited to the in-patient setting in the sleep laboratory, which requires a large number of personnel, and the PSG studies are time-consuming and expensive to conduct. PSG studies are also burdensome for patients, as they require each patient to sleep at the hospital for at least one night while wearing multiple electrodes and other physiological monitoring equipment attached to the head, face, torso, and legs, which makes sleeping difficult and limits movement. A portable PSG device that does not incorporate traditional leads and electrodes would facilitate sleep studies and allow such studies to be done in other locations and be performed more quickly and easily. Studies outside the hospital setting using an optimized, portable PSG device would be easier for sleep technicians to set up and allow each patient to sleep more comfortably.
Onera STS is a wearable system for measuring physiological signals during a PSG study that was designed to overcome the limitations described above that are associated with attended, inpatient PSG. The Onera STS performs electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), and electrocardiography (ECG) and also measures respiratory signals, nasal pressure, oxygen saturation, activity, body position, and snoring loudness via four sensor patches applied to the forehead, upper chest, abdomen, and lower leg. These sensor patches eliminate the need for individual leads and separate electrodes. When used in an in-patient setting, setup time can be reduced compared to the classical PSG setup. The Onera STS system is FDA approved (510k) for the purpose of monitoring physiological parameters intended to provide information which is used to take decisions on the diagnosis of sleep disorders.
The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.
- Conditions
- Sleep Disorder (Disorder)
- Being tested
- Home PSG Assessment
- Keywords
- sleep disordered breathing, sdb, sleep apnea, obstructive sleep apnea, apnea, home PSG, PSG, PSG type 2, PSG type II, sleep diagnostics, home
- Medical subject headings
- Sleep Wake Disorders, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home PSG AssessmentDevice
Testing of the Onera STS in the home environment with the current device shipment method and instructions.
| Study group | Role | What they receive |
|---|---|---|
| Home PSG Assessment | Experimental | Testing of the Onera STS in the home environment with the current device shipment method and instructions. Receives: Device: Home PSG Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Success Rate
Number of studies and reports scored to the AASM Scoring Manual version 2.6, 2020 considered acceptable for clinical use by the lead clinician on the study. A successful sleep study that can be used for diagnostic purposes indicates that the device application and signal collection was successful to assess device feasibility.
Measured: Assessment will be completed within one month after completion of the sleep study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start4 Aug 2023
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
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 Disorder (Disorder)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onera BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881667
- Sponsor's protocol ID
- CIP_Protocol_Onera_D01
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Commercially Sensitive
Publications
Uhles M, Alisic S, Brown A, Doekel R, Booth W, Ojile J. Feasibility and acceptance of self-applied home type-II PSG studies with a patch-based device. Sleep Breath. 2025 Oct 28;29(6):336. doi: 10.1007/s11325-025-03503-z.
PubMed 41148462
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Development and Evaluation Study of a Patch-Based PSG System
- ClinicalTrials.gov ID
- NCT06881667
- Acronym / sponsor ID
- CIP_Protocol_Onera_D01
- Conditions
- Sleep Disorder (Disorder)
- Keywords
- sleep disordered breathing, sdb, sleep apnea, obstructive sleep apnea, apnea, home PSG, PSG, PSG type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Onera BVIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 18 Mar 2025 (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 purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.
Detailed description
The diagnostic gold standard to detect a sleep disorder in the presence of a comorbidity is attended, inpatient, polysomnography (PSG)1. Currently, these tests are limited to the in-patient setting in the sleep laboratory, which requires a large number of personnel, and the PSG studies are time-consuming and expensive to conduct. PSG studies are also burdensome for patients, as they require each patient to sleep at the hospital for at least one night while wearing multiple electrodes and other physiological monitoring equipment attached to the head, face, torso, and legs, which makes sleeping difficult and limits movement. A portable PSG device that does not incorporate traditional leads and electrodes would facilitate sleep studies and allow such studies to be done in other locations and be performed more quickly and easily. Studies outside the hospital setting using an optimized, portable PSG device would be easier for sleep technicians to set up and allow each patient to sleep more comfortably.
Onera STS is a wearable system for measuring physiological signals during a PSG study that was designed to overcome the limitations described above that are associated with attended, inpatient PSG. The Onera STS performs electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), and electrocardiography (ECG) and also measures respiratory signals, nasal pressure, oxygen saturation, activity, body position, and snoring loudness via four sensor patches applied to the forehead, upper chest, abdomen, and lower leg. These sensor patches eliminate the need for individual leads and separate electrodes. When used in an in-patient setting, setup time can be reduced compared to the classical PSG setup. The Onera STS system is FDA approved (510k) for the purpose of monitoring physiological parameters intended to provide information which is used to take decisions on the diagnosis of sleep disorders.
The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home PSG Assessment | Experimental | Device: Home PSG AssessmentTesting of the Onera STS in the home environment with the current device shipment method and instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- Referral for a suspected sleep disorder requiring a sleep diagnostic study
Key exclusion criteria (6 listed)
- Inability to provide informed consent
- History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
- Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
- Has an implanted cardiac stimulator or diaphragmatic pacer
- Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
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 |
|---|---|---|
| Home PSG AssessmentTesting of the Onera STS in the home environment with the current device shipment method and instructions. | Device | Home PSG Assessment |
Primary outcome
Study Success Rate
Time frame: Assessment will be completed within one month after completion of the sleep study.
Number of studies and reports scored to the AASM Scoring Manual version 2.6, 2020 considered acceptable for clinical use by the lead clinician on the study. A successful sleep study that can be used for diagnostic purposes indicates that the device application and signal collection was successful to assess device feasibility.
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 18 Mar 2025.
- Derived from this study: PubMed 41148462Uhles M, Alisic S, Brown A, Doekel R, Booth W, Ojile J. Feasibility and acceptance of self-applied home type-II PSG studies with a patch-based device. Sleep Breath. 2025 Oct 28;29(6):336. doi: 10.1007/s11325-025-03503-z.
- Individual participant dataSharing planned: No. Commercially Sensitive
Related trials for Sleep Disorder (Disorder)
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Not yet recruiting
Visual and Auditory Stimulation in Intensive Care Patients
Dyspnea, Sleep Quality
RecruitingPhase 4
Lemborexant in Delayed Sleep Phase Syndrome
Delayed Sleep Phase Syndrome
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home PSG Assessment in people with Sleep Disorder (Disorder), run by Onera BV 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 2 inclusion and 6 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 18 Mar 2025. 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?
Study Success Rate (time frame: Assessment will be completed within one month after completion of the sleep study.). 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 NCT06881667, 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 18 Mar 2025.