Obstructive Sleep ApneaNCT02205346
Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
Investigate urinary leukotriene E4 levels and determine if there is a correlation with severity of obstructive sleep apnea. The investigators then would like to determine a threshold level which could then be used for confirmation of diagnosis of obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2016
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Otolaryngology practice
Who may be able to join
- children 2-16 years of age
- scheduled for polysomnogram
Who cannot join
- cardiovascular, neuromuscular, immunologic or craniofacial disorders
- pharmacologic treatment including corticosteroids and leukotriene receptor antagonists in the last month
- subjects who have already received treatment for OSA with an oral appliance, continuous positive airway pressure (CPAP) device
- previously undergone tonsillectomy and/or adenoidectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
About this study
Investigate urinary leukotriene E4 levels and determine if there is a correlation with severity of obstructive sleep apnea. The investigators then would like to determine a threshold level which could then be used for confirmation of diagnosis of obstructive sleep apnea (OSA).
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea
- 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.
| Study group | Role | What they receive |
|---|---|---|
| no treatment | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine leukotriene level
assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA
Measured: baseline
Secondary outcomes (1)
correlation between Urine LTE4 and the apnea hypopnea index (AHI)
determine if there is a correlation between urine LTE4 levels and the severity score as determined by the AHI
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionDec 2016
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.
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Medarva
- Responsible party
- Sponsor
- Investigators
- Cristina Baldassari, MD, Principal investigator, EVMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205346
- Sponsor's protocol ID
- October 2013
- Status last verified
- Feb 2018
- First submitted
- 29 Jul 2014
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02205346
- Acronym / sponsor ID
- October 2013
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Medarva
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Jul 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.
Investigate urinary leukotriene E4 levels and determine if there is a correlation with severity of obstructive sleep apnea. The investigators then would like to determine a threshold level which could then be used for confirmation of diagnosis of obstructive sleep apnea (OSA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | –no treatment |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Otolaryngology practice
Key inclusion criteria (2 listed)
- children 2-16 years of age
- scheduled for polysomnogram
Key exclusion criteria (4 listed)
- cardiovascular, neuromuscular, immunologic or craniofacial disorders
- pharmacologic treatment including corticosteroids and leukotriene receptor antagonists in the last month
- subjects who have already received treatment for OSA with an oral appliance, continuous positive airway pressure (CPAP) device
- previously undergone tonsillectomy and/or adenoidectomy
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
urine leukotriene level
Time frame: baseline
assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA
1 secondary outcome
correlation between Urine LTE4 and the apnea hypopnea index (AHI)
Time frame: baseline
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 6 Feb 2018.
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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.
Cristina Baldassari, MD principal investigator
EVMS
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 Obstructive Sleep Apnea, run by Eastern Virginia Medical School at 1 site 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 4 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 6 Feb 2018. 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 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?
urine leukotriene level (time frame: baseline). 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 6 Feb 2018.