Obstructive Sleep ApneaNCT03842618
Asthma Outcomes in Children After Adenotonsillectomy
An observational study of Obstructive Sleep Apnea, run by Assiut University.
Trial summary
The aim of the study is to assess the effect of adenotonsillectomy on level of asthma control in preschool children with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Jun 2021
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Study population: study will be carried out on pre school children with bronchial asthma undergoing adenoidectomy or adenotonsilectomy for obstructive sleep apnea. The study will be conducted in otolaryngology department, Assiut university hospital. The study will be carried on 60 consecutive cases.
Who may be able to join
- preschool children (2_5)years with criteria of bronchial asthma with obstructive sleep apnea regardless sex.
Who cannot join
- patients with other disorders that may cause obstructive sleep apnea as cranio facial syndrome , Down syndrome, cerebral palsy ,obesity,sickle cell disease, low birth weight.
- Any associated medical comorbidity that contraindicates general anesthesia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Adenotonsillectomy on Asthma Control in Preschool Children With Obstructive Sleep Apnea
The aim of the study is to assess the effect of adenotonsillectomy on level of asthma control in preschool children with obstructive sleep apnea.
Read the detailed description
Asthma is the most common chronic disease in children ,in children younger than six years it is difficult to diagnose asthma as pulmonary function tests can not be performed reliably before the age six .
Wheezing is one of the main symptoms of asthma. Young children with multiple trigger wheeze as activities ,laughing and crying are more likely to have asthma compared with episodic (viral) wheeze.
The mainstay of asthma control is daily administration of inhaled corticosteroids, long acting beta2 agonists and avoid exposure of asthma triggers as seasonal allergens and environmental pollution particularly tobacco smoke exposure.
Recent studies have found asthma to be associated with overlapping comorbidities including gastroesophageal reflux,obesity and obstructive sleep apnea.This studies have introduced therapeutic strategies aimed at improving asthma control by management of these coexisting conditions.
Pathophysiological feature of childhood obstructive sleep apnea is presence of increased airway inflammation promoting of hypertrophy of upper airway adenotonsillar tissues .
The latter promotes increased pharyngeal resistance thus predispose the upper airway to episodically collapse and cause fragmented sleep that characterize obstructive sleep apnea.
Surgically adenotonsillectomy is the first line of therapy in childhood obstructive sleep apnea and has favorable outcomes ,including improvements of respiratory sleep disturbances and in reducing markers of asthma and reduction in the use of asthma therapies.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- asthma- obstructive sleep apnea-adenotonsillectomy
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
preschool children who suffer from bronchial asthma will be assessed by questionnaire based history to assess level of asthma control as stated in GINA 2018 before and after adenotonsillectomy.
Questionnaire based history will be obtained from the parents of children before adenotonsillectomy to assess level of asthma control in preschool children as stated in Global Initiative for Asthma (GINA 2018); ask parents in the past 4 weeks, has child had A-Day time asthma symptoms for more than a few minutes, more than once a week? B-Any activity limitation due to asthma? (Runs, tires easily, playing?) C-Reliever medication needed more than once a week? D-Any night waking or night coughing due to asthma? The child will be well controlled if none of this question were answered by yes.
The child will be partially controlled if 1-2 of this question were answered by yes.
The child will be un controlled if 3-4 of these questions were answered by yes. Repeat this questions after adenotonsillectomy to show prognosis of asthma after surgery.
Measured: up to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (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 Assiut UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Shafeek Ibrahiem Ghali, Assiut University
- Investigators
- Diana shafeek Ibrahiem Ghali, Resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842618
- Sponsor's protocol ID
- AOICAA
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adenotonsillectomy on Asthma Control in Preschool Children With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03842618
- Acronym / sponsor ID
- AOICAA
- Conditions
- Obstructive Sleep Apnea
- Keywords
- asthma- obstructive sleep apnea-adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 15 Feb 2019 (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 aim of the study is to assess the effect of adenotonsillectomy on level of asthma control in preschool children with obstructive sleep apnea.
Detailed description
Asthma is the most common chronic disease in children ,in children younger than six years it is difficult to diagnose asthma as pulmonary function tests can not be performed reliably before the age six .
Wheezing is one of the main symptoms of asthma. Young children with multiple trigger wheeze as activities ,laughing and crying are more likely to have asthma compared with episodic (viral) wheeze.
The mainstay of asthma control is daily administration of inhaled corticosteroids, long acting beta2 agonists and avoid exposure of asthma triggers as seasonal allergens and environmental pollution particularly tobacco smoke exposure.
Recent studies have found asthma to be associated with overlapping comorbidities including gastroesophageal reflux,obesity and obstructive sleep apnea.This studies have introduced therapeutic strategies aimed at improving asthma control by management of these coexisting conditions.
Pathophysiological feature of childhood obstructive sleep apnea is presence of increased airway inflammation promoting of hypertrophy of upper airway adenotonsillar tissues .
The latter promotes increased pharyngeal resistance thus predispose the upper airway to episodically collapse and cause fragmented sleep that characterize obstructive sleep apnea.
Surgically adenotonsillectomy is the first line of therapy in childhood obstructive sleep apnea and has favorable outcomes ,including improvements of respiratory sleep disturbances and in reducing markers of asthma and reduction in the use of asthma therapies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- study will be carried out on pre school children with bronchial asthma undergoing adenoidectomy or adenotonsilectomy for obstructive sleep apnea. The study will be conducted in otolaryngology department, Assiut university hospital. The study will be carried on 60 consecutive cases.
Key inclusion criteria (1 listed)
- preschool children (2_5)years with criteria of bronchial asthma with obstructive sleep apnea regardless sex.
Key exclusion criteria (2 listed)
- patients with other disorders that may cause obstructive sleep apnea as cranio facial syndrome , Down syndrome, cerebral palsy ,obesity,sickle cell disease, low birth weight.
- Any associated medical comorbidity that contraindicates general anesthesia.
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
preschool children who suffer from bronchial asthma will be assessed by questionnaire based history to assess level of asthma control as stated in GINA 2018 before and after adenotonsillectomy.
Time frame: up to 1year
Questionnaire based history will be obtained from the parents of children before adenotonsillectomy to assess level of asthma control in preschool children as stated in Global Initiative for Asthma (GINA 2018); ask parents in the past 4 weeks, has child had A-Day time asthma symptoms for more than a few minutes, more than once a week? B-Any activity limitation due to asthma? (Runs, tires easily, playing?) C-Reliever medication needed more than once a week? D-Any night waking or night coughing due to asthma? The child will be well controlled if none of this question were answered by yes. The child will be partially controlled if 1-2 of this question were answered by yes. The child will be un controlled if 3-4 of these questions were answered by yes. Repeat this questions after adenotonsillectomy to show prognosis of asthma after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Diana shafeek Ibrahiem Ghali, Resident principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Assiut University.
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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Ali Ragaei Abd El-Hakim, prof.dr. (01115444779, alyragie@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preschool children who suffer from bronchial asthma will be assessed by questionnaire based history to assess level of asthma control as stated in GINA 2018 before and after adenotonsillectomy. (time frame: up to 1year). 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 15 Feb 2019.