Sleep Disordered Breathing (SDB)NCT02040701
Sleep Disordered Breathing in Children: Inflammation and Oxidative Stress
An observational study of Sleep Disordered Breathing (SDB) and Endothelial Dysfunction, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to measure markers of inflammatory and oxidative stress known to be associated with cardiovascular morbidity in snoring children. In addition, to measure markers of local inflammation and to evaluate the response to treatment. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disordered Breathing (SDB), Endothelial Dysfunction
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to May 2014
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children ages 6 months-18 years who will undergo overnight sleep study at the Dana Children's hospital, Tel Aviv Medical Center because of snoring and suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy
Who may be able to join
- children ages 6 months-18 years
- suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy
Who cannot join
- craniofacial abnormalities
- neurological disorders
- genetic disorders
- infectious disease
- chronic inflammatory disease
- any underlying chronic medical condition
Trial locations and contacts
1 site in 1 country.
Riva Tauman, Dr. contact
Israel1 site, 1 recruiting
- Recruiting
Dana Children's hospital, Tel Aviv Medical Center
Tel Aviv
Riva Tauman, Dr., tauman@tlvmc.gov.il
Riva Tauman, Dr.
About this study
The purpose of the study is to measure markers of inflammatory and oxidative stress known to be associated with cardiovascular morbidity in snoring children.
In addition, to measure markers of local inflammation and to evaluate the response to treatment.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| SDB group | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma inflammatory-markers
Sleep disordered breathing (SDB) in children is associated with increased markers of inflammation, atherogenesis and oxidative stress.
Measured: After the blood analyzed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startMay 2006
- Primary completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered Breathing (SDB)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040701
- Sponsor's protocol ID
- TASMC-13-RT-06-122-CTIL
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing in Children: Inflammation and Oxidative Stress
- ClinicalTrials.gov ID
- NCT02040701
- Acronym / sponsor ID
- TASMC-13-RT-06-122-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2006
- Primary completion
- May 2014 (estimated)
- First posted
- 20 Jan 2014 (estimated)
- 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 the study is to measure markers of inflammatory and oxidative stress known to be associated with cardiovascular morbidity in snoring children.
In addition, to measure markers of local inflammation and to evaluate the response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDB group | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children ages 6 months-18 years who will undergo overnight sleep study at the Dana Children's hospital, Tel Aviv Medical Center because of snoring and suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy
Key inclusion criteria (2 listed)
- children ages 6 months-18 years
- suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy
Key exclusion criteria (6 listed)
- craniofacial abnormalities
- neurological disorders
- genetic disorders
- infectious disease
- chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma inflammatory-markers
Time frame: After the blood analyzed
Sleep disordered breathing (SDB) in children is associated with increased markers of inflammation, atherogenesis and oxidative stress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
Related trials for Sleep Disordered Breathing (SDB)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
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.
Riva Tauman, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disordered Breathing (SDB) and Endothelial Dysfunction, 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 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: status not confirmed, as of the sponsor's last update on 20 Jan 2014. 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.
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 Riva Tauman, Dr. (tauman@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma inflammatory-markers (time frame: After the blood analyzed). 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 20 Jan 2014.