Obstructive Sleep ApneaEarly Phase 1O2SLEEPNCT04321083
Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea
A Early Phase 1 study testing INVOS in people with Obstructive Sleep Apnea and Pediatric Sleep Apnea, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The gold standard of obstructive sleep apnea (OSA) is (PSG)POLYSOMNOGRAPHY. During the examination, the patient is monitored by saturation, EEG and other measurements. Near infrared spectroscopy is an uprising technology allowing non invasive measurement of the frontal lobe oxygenation. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Obstructive Sleep Apnea, Pediatric Sleep Apnea
- What is being tested?
- INVOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Sep 2019to 31 Dec 2022
- Phase
- Early Phase 1
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4-16 y/o pediatric population referred for PSG in Dana Hospital
Who cannot join
- down synd.
- craniofacial malformation
- PPD
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Dana Duek pediatric hospital TASMC
Tel Aviv
Ari DeRowe, Prof, 0524266357, AriD@tlvmc.gov.il
About this study
The gold standard of obstructive sleep apnea (OSA) is (PSG)POLYSOMNOGRAPHY. During the examination, the patient is monitored by saturation, EEG and other measurements.
Near infrared spectroscopy is an uprising technology allowing non invasive measurement of the frontal lobe oxygenation. It is painless and does not have side effects. We believe that brain saturation will be more accurate then peripheral pulse oximeter and will be better correlated with the clinical presentation of OSA.
Read the detailed description
a prospective cohort study study group - pediatric population referred to PSG in Dana Duek Hospital. After informed consent received from the parents, the parents will fulfill "Connors" (age 6 +) \& "Brief" (age 4-6) questionnaires.
During the PSG, the brain saturation will be monitored by INVOS(TM) Medtronic device. They will be monitored \& synchronized with the peripheral saturation documented performed as part of the PSG examination.
The brain saturation \& peripheral saturation levels will be compared and both will be correlated to the questionnaires \& AHI.
- Conditions
- Obstructive Sleep Apnea, Pediatric Sleep Apnea
- Being tested
- INVOS
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVOSDiagnostic test
INVOS monitoring brain o2 saturation
| Study group | Role | What they receive |
|---|---|---|
| O2 brain (central) measurement | Experimental | INVOS will be applied simultaneously for monitoring along with the regular polysomnography (sleep lab) workup Receives: Diagnostic Test: INVOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between brain o2 levels to peripheral measurements
correlation between brain o2 levels to peripheral measurements
Measured: procedure (during the examination PGS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start11 Sep 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- INVOS Medtronic device will be applied simultaneously with sleep lab monitoring
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ari Derowe, prof, Principal investigator, Dana Duek pediatric hospital, TASMC, TA, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321083
- Sponsor's protocol ID
- TASMC18AD078918CTIL
- Acronym
- O2SLEEP
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04321083
- Acronym / sponsor ID
- O2SLEEP / TASMC18AD078918CTIL
- Conditions
- Obstructive Sleep Apnea, Pediatric Sleep Apnea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Mar 2020 (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 gold standard of obstructive sleep apnea (OSA) is (PSG)POLYSOMNOGRAPHY. During the examination, the patient is monitored by saturation, EEG and other measurements.
Near infrared spectroscopy is an uprising technology allowing non invasive measurement of the frontal lobe oxygenation. It is painless and does not have side effects. We believe that brain saturation will be more accurate then peripheral pulse oximeter and will be better correlated with the clinical presentation of OSA.
Detailed description
a prospective cohort study study group - pediatric population referred to PSG in Dana Duek Hospital. After informed consent received from the parents, the parents will fulfill "Connors" (age 6 +) \& "Brief" (age 4-6) questionnaires.
During the PSG, the brain saturation will be monitored by INVOS(TM) Medtronic device. They will be monitored \& synchronized with the peripheral saturation documented performed as part of the PSG examination.
The brain saturation \& peripheral saturation levels will be compared and both will be correlated to the questionnaires \& AHI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- INVOS Medtronic device will be applied simultaneously with sleep lab monitoring
| Arm | Type | Receives |
|---|---|---|
| O2 brain (central) measurement | Experimental | Diagnostic Test: INVOSINVOS will be applied simultaneously for monitoring along with the regular polysomnography (sleep lab) workup |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 4-16 y/o pediatric population referred for PSG in Dana Hospital
Key exclusion criteria (3 listed)
- down synd.
- craniofacial malformation
- PPD
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 |
|---|---|---|
| INVOSINVOS monitoring brain o2 saturation | Diagnostic test | O2 brain (central) measurement |
Primary outcome
correlation between brain o2 levels to peripheral measurements
Time frame: procedure (during the examination PGS)
correlation between brain o2 levels to peripheral measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Ari Derowe, prof principal investigator
Dana Duek pediatric hospital, TASMC, TA, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing INVOS in people with Obstructive Sleep Apnea and Pediatric Sleep Apnea, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ari DeRowe, prof (05246266357, arid@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between brain o2 levels to peripheral measurements (time frame: procedure (during the examination PGS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2020.