Obstructive Sleep ApneaNCT05421403
The Interplay Between Obstructive Sleep Apnea Cognitive Dysfunction in Pediatric Patients
A study testing adenotonsillectomy and Lifestyle intervention in people with Obstructive Sleep Apnea, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Objectives: Determination of the impact of obstructive sleep apnea (OSA) on the cognitive function (CF) and serum tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and 1β levels in children aged 5-12 years and the effect of OSA management on these variables. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- adenotonsillectomy and Lifestyle intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Nov 2020to 15 Jun 2021
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in age range of 5-12 years with mild-to-severe OSAS, free of exclusion criteria were enrolled in the study.
Who cannot join
- The presence of craniofacial anomalies
- neurological disorders
- very severe OSAS
- OSAS complicated by complex comorbidities
- residual OSAS following adenotonsillectomy (AT), hypothyroidism, or refusal of the suggested therapeutic plans.
- children who failed or were unable to undergo the cognitive function evaluation and those whose parents refused to undergo polysomnography were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Interplay Between Obstructive Sleep Apnea and Inflammatory Cytokines Induces Cognitive Dysfunction in Pediatric Patients
Objectives: Determination of the impact of obstructive sleep apnea (OSA) on the cognitive function (CF) and serum tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and 1β levels in children aged 5-12 years and the effect of OSA management on these variables.
Patients \& Methods: 224 patients were evaluated using the Pediatric Sleep Questionnaire, the NEPSY score for CF and Polysomnography (PSG) to grade OSA severity according to the Apnea/hypopnea index (AHI). Patients with adenotonsillar hypertrophy grade >2 will undergo the appropriate surgical intervention. Overweight or obese patients with mild or moderate OSAS will undergo 6-m trial of lifestyle intervention (LSI). Blood samples were obtained for ELISA estimation of cytokines' levels. At end of 6-m follow-up, all variables were re-evaluated
Read the detailed description
All children aged 5-12 years who attended the outpatient clinics of Otorhinolaryngology and/or Pediatrics with complaints suggestive of OSAS were eligible for evaluation for exclusion and inclusion criteria according to the conditions of the Local Ethical Committee which approved the study protocol by number.
Evaluation Tools
- Evaluation of body mass index (BMI): BMI was calculated according to Bray as weight (kg) divided by the square height (m2) and was interpreted according to the International Obesity Task Force (IOTF) BMI cut-offs according to the percentile of BMI adjusted for age and gender.
- Pediatric Sleep Questionnaire (PSQ) using the sleep-related breathing disorders scale which consists of 3 domains including 22 items with three responses to each item Yes (=1), No (=0), and don't know = missed answer.
- Neurocognitive Assessments using the NEPSY II score which is designed to assess six domains (Appendix 2), each domain was expressed as scaled scores with lower scores indicating cognitive dysfunction.
- Otorhinolaryngologic assessment variables:
- Assessment of the volume of the palatine tonsils using Brodsky grading scale Adenoid size was assessed by X-Ray soft tissue nasopharynx lateral view and graded according to. Assessment of the tongue position within the oral cavity to evaluate the extent of obstruction of the oral cavity by the tongue using the modified Mallampati method.
- Polysomnography (PSG) was performed according to guidelines of the American Academy of Sleep Medicine (AASM) for the scoring of sleep and associated events. The hypopnea index (HI) indicated the number of hypopneas per hour of sleep and the Apnea/hypopnea index (AHI) is the summation of apnea and hypopnea indices.
- Laboratory investigation: Venous blood samples (5 ml) were collected for ELISA estimation of serum levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-6, and 1β.
Diagnosis and grading of OSAS
- Diagnosis of OSAS: Pediatric OSAS was diagnosed according to guidelines of the American Academy of Sleep Medicine (21) depending on both the clinical findings and the polysomnographic criteria for diagnosis.
- OSAS severity grading OSAS severity was graded according to the apnea-hypopnea index (AHI) into mild if AHI was 1-4.9, moderate if AHI 5-9.9, or severe if AHI > 10 and if AHI was >30 OSAS is very severe.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- adenotonsillectomy, Lifestyle intervention
- 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.
adenotonsillectomyProcedure or surgery
all patients with adenoid or tonsillar or adenotonsillar hypertrophy of grade >2 will undergo adenoidectomy, tonsillectomy or adenotonsillectomy (AT) according to the indication. Overweight or obese patients with mild or moderate OSAS will undergo 6-m trial of lifestyle intervention (LSI) and CPAP if indicated, responders will undergo more follow-up otherwise surgical interference was indicated
Lifestyle interventionBehavioural
After baseline testing, all subjects began a structured 6-month LSI consisting of dietary modification and exercise. Intensive dietary counseling was provided weekly for the first 4 weeks of the intervention, monthly subsequently until 6 months. A target caloric deficit of ~250.500 cal/d was recommended throughout dietary counseling. Dietary regimen consisted of diets composed of nutrients contributing to total energy as 55% carbohydrate, 15% protein, and 30% fat. Other lifestyle changes included calorie restriction depending on reduction of the frequency of snack consumption, ingestion of low-calorie and low-fat snacks, limiting sugar-based carbonated drinks and the duration of television watching or mobile games. Exercise sessions consisted of both aerobic and strength training three times weekly.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Active comparator | Not described Receives: Procedure: adenotonsillectomy |
| non-Surgical | Placebo comparator | Not described Receives: Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relive of OSAS
The effect of relieve of obstruction on sleep-related breathing disorders and cognitive function as judged by the Pediatric Sleep Questionnaire at end of follow up
Measured: 6 months
Effect of weight reduction on sleep-related breathing disorders
The effect of relieve of obstruction and weight reduction on sleep-related breathing disorders as judged by the NESPY score at end of follow up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start7 Nov 2020
- Primary completion1 Mar 2021
- Study completion15 Jun 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Wahbaa, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421403
- Sponsor's protocol ID
- AUAREC20190509-12
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interplay Between Obstructive Sleep Apnea and Inflammatory Cytokines Induces Cognitive Dysfunction in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05421403
- Acronym / sponsor ID
- AUAREC20190509-12
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 16 Jun 2022 (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.
Objectives: Determination of the impact of obstructive sleep apnea (OSA) on the cognitive function (CF) and serum tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and 1β levels in children aged 5-12 years and the effect of OSA management on these variables.
Patients \& Methods: 224 patients were evaluated using the Pediatric Sleep Questionnaire, the NEPSY score for CF and Polysomnography (PSG) to grade OSA severity according to the Apnea/hypopnea index (AHI). Patients with adenotonsillar hypertrophy grade >2 will undergo the appropriate surgical intervention. Overweight or obese patients with mild or moderate OSAS will undergo 6-m trial of lifestyle intervention (LSI). Blood samples were obtained for ELISA estimation of cytokines' levels. At end of 6-m follow-up, all variables were re-evaluated
Detailed description
All children aged 5-12 years who attended the outpatient clinics of Otorhinolaryngology and/or Pediatrics with complaints suggestive of OSAS were eligible for evaluation for exclusion and inclusion criteria according to the conditions of the Local Ethical Committee which approved the study protocol by number.
Evaluation Tools
- Evaluation of body mass index (BMI): BMI was calculated according to Bray as weight (kg) divided by the square height (m2) and was interpreted according to the International Obesity Task Force (IOTF) BMI cut-offs according to the percentile of BMI adjusted for age and gender.
- Pediatric Sleep Questionnaire (PSQ) using the sleep-related breathing disorders scale which consists of 3 domains including 22 items with three responses to each item Yes (=1), No (=0), and don't know = missed answer.
- Neurocognitive Assessments using the NEPSY II score which is designed to assess six domains (Appendix 2), each domain was expressed as scaled scores with lower scores indicating cognitive dysfunction.
- Otorhinolaryngologic assessment variables:
- Assessment of the volume of the palatine tonsils using Brodsky grading scale Adenoid size was assessed by X-Ray soft tissue nasopharynx lateral view and graded according to. Assessment of the tongue position within the oral cavity to evaluate the extent of obstruction of the oral cavity by the tongue using the modified Mallampati method.
- Polysomnography (PSG) was performed according to guidelines of the American Academy of Sleep Medicine (AASM) for the scoring of sleep and associated events. The hypopnea index (HI) indicated the number of hypopneas per hour of sleep and the Apnea/hypopnea index (AHI) is the summation of apnea and hypopnea indices.
- Laboratory investigation: Venous blood samples (5 ml) were collected for ELISA estimation of serum levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-6, and 1β.
Diagnosis and grading of OSAS
- Diagnosis of OSAS: Pediatric OSAS was diagnosed according to guidelines of the American Academy of Sleep Medicine (21) depending on both the clinical findings and the polysomnographic criteria for diagnosis.
- OSAS severity grading OSAS severity was graded according to the apnea-hypopnea index (AHI) into mild if AHI was 1-4.9, moderate if AHI 5-9.9, or severe if AHI > 10 and if AHI was >30 OSAS is very severe.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical | Active comparator | Procedure: adenotonsillectomy |
| non-Surgical | Placebo comparator | Behavioral: Lifestyle intervention |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children in age range of 5-12 years with mild-to-severe OSAS, free of exclusion criteria were enrolled in the study.
Key exclusion criteria (6 listed)
- The presence of craniofacial anomalies
- neurological disorders
- very severe OSAS
- OSAS complicated by complex comorbidities
- residual OSAS following adenotonsillectomy (AT), hypothyroidism, or refusal of the suggested therapeutic plans.
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 |
|---|---|---|
| adenotonsillectomyall patients with adenoid or tonsillar or adenotonsillar hypertrophy of grade >2 will undergo adenoidectomy, tonsillectomy or adenotonsillectomy (AT) according to the indication. Overweight or obese patients with mild or moderate OSAS will undergo 6-m trial of lifestyle intervention (LSI) and CPAP if indicated, responders will undergo more follow-up otherwise surgical interference was indicated | Procedure or surgery | Surgical |
| Lifestyle interventionAfter baseline testing, all subjects began a structured 6-month LSI consisting of dietary modification and exercise. Intensive dietary counseling was provided weekly for the first 4 weeks of the intervention, monthly subsequently until 6 months. A target caloric deficit of ~250.500 cal/d was recommended throughout dietary counseling. Dietary regimen consisted of diets composed of nutrients contributing to total energy as 55% carbohydrate, 15% protein, and 30% fat. Other lifestyle changes included calorie restriction depending on reduction of the frequency of snack consumption, ingestion of low-calorie and low-fat snacks, limiting sugar-based carbonated drinks and the duration of television watching or mobile games. Exercise sessions consisted of both aerobic and strength training three times weekly. | Behavioural | non-Surgical |
Primary outcome
Relive of OSAS
Time frame: 6 months
The effect of relieve of obstruction on sleep-related breathing disorders and cognitive function as judged by the Pediatric Sleep Questionnaire at end of follow up
Effect of weight reduction on sleep-related breathing disorders
Time frame: 6 months
The effect of relieve of obstruction and weight reduction on sleep-related breathing disorders as judged by the NESPY score at end of follow up
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 16 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adenotonsillectomy and Lifestyle intervention in people with Obstructive Sleep Apnea, run by Al-Azhar University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 16 Jun 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Relive of OSAS (time frame: 6 months). The study lists 2 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 16 Jun 2022.