Sleep Disordered BreathingNCT02043353
The Natural History and Outcome of Sleep Disordered Breathing in Children
An observational study of Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Sleep-disordered breathing in children is characterized by recurrent events of partial or complete upper airway obstruction during sleep, resulting in disruption of normal gas exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. The major symptom is snoring or noisy breathing. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Sleep Disordered Breathing, Obstructive Sleep Apnea
- How many people
- 2,856 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Sep 2014
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Healthy children 0-18 years old that underwent PSG evaluation at the Pediatric Sleep Center at Dana Children's hospital between 2005-2010
Who may be able to join
- healthy normally developing children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010
Who cannot join
- Chronic medical and neurodevelopmental conditions.
- Congenital anomalies.
Trial locations and contacts
1 site in 1 country.
Riva Tauman, Dr. contact
Israel1 site, 1 recruiting
- Recruiting
Sourasky Medical Center
Tel Aviv
Riva Tauman, Dr
About this study
Sleep-disordered breathing in children is characterized by recurrent events of partial or complete upper airway obstruction during sleep, resulting in disruption of normal gas exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. The major symptom is snoring or noisy breathing. Sleep Disordered Breathing (SDB) is a wide spectrum of disorders that includes primary snoring, UARS and OSA. The main etiology for SDB in children is enlarged tonsils and adenoids and therefore the first line of treatment in pediatric SDB is adenotonsillectomy.
The objectives of this study are:
- To investigate the natural history of primary snoring
- To investigate the effect of seasonality on SDB severity
- To compare the effect of adenoidectomy to adenotonsillectomy in the treatment of SDB in children
- To characterize the children referred for repeated PSG following adenoidectomy or adenotonsillectomy and the indications for second PSG evaluation.
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
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 |
|---|---|---|
| Winter Vs. Summer | All children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010 | |
| Primary snoring | All children that were diagosed with primary snoring at the Tel Aviv Medical center between 2005-2010 | |
| Adenotonsillectomy Vs. Adenoidectomy | All children that underwent adenotonsillectomy or tonsillectomy at the Tel Aviv Medical center between 2005-2008 | |
| repeated PSG | All children that underwent Adenoidectomy / Adenotonsillectomy and two PSG evaluations at the Tel Aviv Medical center between 2005-2012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Snoring
Snoring will be assesd by PSQ-Pediatric sleep questionnaire
Measured: 4 years
OSA severity (AHI, mean SpO2, SPo2 nadir)
Measured: 4 years
Daytime function
Daytime function will be assesd by PSQ-Pediatric sleep questionnaire
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startAug 2010
- Primary completionSep 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 BreathingStudies 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
- Retrospective
- Enrolment
- 2,856 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043353
- Sponsor's protocol ID
- TASMC-14-RT-03-5510-CTIL
- Status last verified
- Jan 2014
- First submitted
- 12 Jan 2014
- Last updated
- 23 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History and Outcome of Sleep Disordered Breathing in Children
- ClinicalTrials.gov ID
- NCT02043353
- Acronym / sponsor ID
- TASMC-14-RT-03-5510-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,856 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2010
- Primary completion
- Sep 2014 (estimated)
- First posted
- 23 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.
Sleep-disordered breathing in children is characterized by recurrent events of partial or complete upper airway obstruction during sleep, resulting in disruption of normal gas exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. The major symptom is snoring or noisy breathing. Sleep Disordered Breathing (SDB) is a wide spectrum of disorders that includes primary snoring, UARS and OSA. The main etiology for SDB in children is enlarged tonsils and adenoids and therefore the first line of treatment in pediatric SDB is adenotonsillectomy.
The objectives of this study are:
- To investigate the natural history of primary snoring
- To investigate the effect of seasonality on SDB severity
- To compare the effect of adenoidectomy to adenotonsillectomy in the treatment of SDB in children
- To characterize the children referred for repeated PSG following adenoidectomy or adenotonsillectomy and the indications for second PSG evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Winter Vs. Summer | – | –All children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010 |
| Primary snoring | – | –All children that were diagosed with primary snoring at the Tel Aviv Medical center between 2005-2010 |
| Adenotonsillectomy Vs. Adenoidectomy | – | –All children that underwent adenotonsillectomy or tonsillectomy at the Tel Aviv Medical center between 2005-2008 |
| repeated PSG | – | –All children that underwent Adenoidectomy / Adenotonsillectomy and two PSG evaluations at the Tel Aviv Medical center between 2005-2012 |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Healthy children 0-18 years old that underwent PSG evaluation at the Pediatric Sleep Center at Dana Children's hospital between 2005-2010
Key inclusion criteria (1 listed)
- healthy normally developing children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010
Key exclusion criteria (2 listed)
- Chronic medical and neurodevelopmental conditions.
- Congenital anomalies.
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
Snoring
Time frame: 4 years
Snoring will be assesd by PSQ-Pediatric sleep questionnaire
OSA severity (AHI, mean SpO2, SPo2 nadir)
Time frame: 4 years
Daytime function
Time frame: 4 years
Daytime function will be assesd by PSQ-Pediatric sleep questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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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.
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 and Obstructive 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 2 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 23 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?
Snoring (time frame: 4 years). The study lists 3 primary outcomes in all. 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 23 Jan 2014.