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| Name | Class |
|---|---|
| Aghia Sophia Children's Hospital of Athens | OTHER |
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Obstructive sleep-disordered breathing (SDB) in childhood is a disorder of breathing during sleep characterized by intermittent upper airway obstruction. Snoring, labored breathing and apneas reported by the parents are the most frequent symptoms.Obstructive SDB can result from many different abnormalities including large adenoids and tonsils or obesity.
Intermittent upper airway obstruction during sleep is accompanied by low oxygen or high carbon dioxide in the blood and arousals from sleep. If obstructive SDB is not treated, complications may develop such as: i) enuresis; ii) delay in somatic growth rate; iii) central nervous system morbidity (e.g. hyperactivity and learning difficulties); and iv) elevated blood pressure.
Overnight polysomnography (PSG) is considered the gold-standard method for defining severity of obstructive SDB and subgroups of children with snoring who should be treated. However, PSG is a labor-intensive, time-consuming and expensive diagnostic method, which is not available in many community settings. Thus, there is an urgent need for developing easy-to-use and low-cost diagnostic methods which can be used to determine severity of obstructive SDB and define subgroups of children with snoring and large adenoids and tonsils who will benefit from adenotonsillectomy (AT).
Pulse oximetry is a widely available, non-invasive method which allows continuous monitoring of oxygen transport by hemoglobin. Episodes of upper airway obstruction are frequently accompanied by reductions in the hemoglobin oxygen transport (oxygen desaturation of hemoglobin).The hypothesis of this research project is that subgroups of children with snoring and adenotonsillar hypertrophy and certain abnormalities in oxygenation detected by nocturnal pulse oximetry will benefit from AT in a community setting.
Time in the waiting list for undergoing AT at the Department of Otorhinolaryngology, Chania General Hospital "St. George" is approximately 3 months. In the present study, children will be recruited and randomized in the Active Comparator (AT group) or in the Control Group (No AT group) at the time of the initial clinic visit, if they fulfill the Inclusion Criteria and their parents consent to participation in the study.
Children in the AT group will undergo the baseline study evaluation at the end of the 3-month waiting time and thus immediately prior to AT. They will also undergo the follow-up study evaluation at 3 months postoperatively.
Children in the Control group will undergo their baseline study evaluation at the time of entering the surgical waiting list. They will undergo the follow-up study evaluation 3 months later, immediately prior to AT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT (adenotonsillectomy) Group | Active Comparator | AT (adenotonsillectomy) immediately after the baseline study evaluation |
|
| Control Group | No Intervention | No AT (adenotonsillectomy) for 3 months after the baseline study evaluation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenotonsillectomy (AT) | Procedure | Standard surgical intervention for treatment of obstructive sleep-disordered (SDB). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Subjects Without Oxygenation Abnormalities | Change in number of participants with a McGill oximetry score =1 (usual oxygen saturation of hemoglobin-SpO2>95%; fewer than 3 drops below 90%; and fewer than 3 clusters of desaturation events) between 3 months and 0 months. McGill oximetry score=1: normal or inconclusive nocturnal oximetry; McGill oximetry score=2: mild hypoxemia; McGill oximetry score=3: moderate hypoxemia; McGill oximetry score=4: severe hypoxemia. | 3 months (follow-up), 0 months (baseline) |
| Change in Number of Subjects Without Oxygenation Abnormalities | Number of subjects who achieved a desaturation index (≥3% drop) of <2 episodes/h at 3 months (follow-up), if they had a desaturation index of ≥ 3.5 episodes/h at 0 months (baseline) | 3 months (follow-up), 0 months (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms Predicting Obstructive Sleep Apnea (OSA) | Change in Pediatric Sleep Questionnaire sleep-related breathing disorder (PSQ-SRBD) scale, between follow-up and baseline. PSQ-SRBD scale ranges between 0 and 1. PSQ-SRBD score <0.33 is associated with low risk of apnea-hypopnea index >5 episodes/h; PSQ-SRBD score >=0.33 is associated with high risk of apnea-hypopnea index >5 episodes/h. | 3 months (follow-up), 0 months (baseline) |
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Inclusion Criteria:
Exclusion Criteria:
Footnote
Brodsky score Upon inspection of the oropharynx
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| Name | Affiliation | Role |
|---|---|---|
| Chariton E. Papadakis, MD | Chania General Hospital "St. George" | Study Director |
| Athanasios G. Kaditis, MD | Aghia Sophia Children's Hospital of Athens | Study Chair |
| Theognosia S. Chimona, MD | Chania General Hospital "St. George" | Principal Investigator |
| Panagiota N. Asimakopoulou, MD | Chania General Hospital "St. George" | Principal Investigator |
| Efklidis Proimos, MD | Chania General Hospital "St. George" | Principal Investigator |
| Konstantinos Chaidas, MD | Aghia Sophia Children's Hospital of Athens | Principal Investigator |
| Alexandra Klimentopoulou, MD | Aghia Sophia Children's Hospital of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aghia Sophia Children's Hospital of Athens | Athens | 11527 | Greece | |||
| Chania General Hospital "St. George" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14702490 | Background | Nixon GM, Kermack AS, Davis GM, Manoukian JJ, Brown KA, Brouillette RT. Planning adenotonsillectomy in children with obstructive sleep apnea: the role of overnight oximetry. Pediatrics. 2004 Jan;113(1 Pt 1):e19-25. doi: 10.1542/peds.113.1.e19. | |
| 16997385 | Background | Saito H, Araki K, Ozawa H, Mizutari K, Inagaki K, Habu N, Yamashita T, Fujii R, Miyazaki S, Ogawa K. Pulse-oximetery is useful in determining the indications for adeno-tonsillectomy in pediatric sleep-disordered breathing. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):1-6. doi: 10.1016/j.ijporl.2006.08.009. Epub 2006 Sep 25. |
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Recruitment between June 2013 and April 2016; ENT Clinic of a Regional Hospital in Greece (Chania, Crete).
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| ID | Title | Description |
|---|---|---|
| FG000 | AT (Adenotonsillectomy) Group | Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB. |
| FG001 | Control Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Quality of Life (OSA-18 Score) | Change in obstructive sleep apnea (OSA)-18 total score between follow-up and baseline. OSA-18 is a quality of life survey including 18 questions on sleep disturbance, physical symptoms, emotional symptoms, daytime function and caregiver concerns. It is used to assess the impact of obstructive sleep apnea on child's life. Scores less than 60 suggest a small impact, between 60 and 80 moderate impact and above 80 a large impact. OSA-18 score ranges between 18 and 126. | 3 months (follow-up), 0 months (baseline) |
| Sleepiness | Change in Modified Epworth Sleepiness Scale between follow-up and baseline Modified Epworth Sleepiness Scale ranges from 0 to 24; higher score indicates more daytime sleepiness. | 3 months (follow-up), 0 months (baseline) |
| Somatic Growth-1 | Percent of subjects achieving an increase in weight z-score of at least 0.5. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. | 0 months (baseline), 3 months (follow-up) |
| Somatic Growth-2 | Percent of subjects achieving an increase in body mass index z-score of at least 0.5. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population, | 0 months (baseline), 3 months (follow-up) |
| Enuresis | Percent of subjects who achieved frequency of nocturnal enuresis < 1 night per week at follow-up (3 months), if they had incontinence at least 1 night per week at baseline (0 months). | 3 months (follow-up), 0 months (baseline) |
| Cardiovascular Effects-1 | Change in mean pulse rate between follow-up and baseline. | 3 months (follow-up), 0 months (baseline) |
| Cardiovascular Effects-2 | Change in mean frequency of pulse rate rises (at least 6 beats per min) between follow-up and baseline. | 3 months (follow-up), 0 months (baseline) |
| Cardiovascular Effects-3 | Change in morning systolic blood pressure z-score between follow-up and baseline. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population, | 3 months (follow-up), 0 months (baseline) |
| Cardiovascular Effects-4 | Change in morning diastolic blood pressure z-score between follow-up and baseline. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population, | 3 months (follow-up), 0 months (baseline) |
| Systemic Inflammation | Change in morning serum C-reactive protein concentration between follow-up and baseline. | 3 months (follow-up), 0 months (baseline) |
| Improvement in Baseline SpO2 | Proportion of subjects who had an increase from baseline in SpO2 of >1.6% | 3 months (follow-up), 0 months (baseline) |
| Behavioral Abnormalities-1 | Change in the DuPaul Questionnaire for Parents score between follow-up and baseline. | 3 months (follow-up), 0 months (baseline) |
| Behavioral Abnormalities-2 | Change in the Achenbach Questionnaire for Parents score between follow-up and baseline. | 3 months (follow-up), 0 months (baseline) |
| Effects on Sympathetic Nervous System Activation | Change in ratio of morning urine norepinephrine concentration to urine creatinine concentration between follow-up and baseline. | 3 months (follow-up), 0 months (baseline) |
| Chania |
| 73300 |
| Greece |
| 18684748 | Background | Bonuck KA, Freeman K, Henderson J. Growth and growth biomarker changes after adenotonsillectomy: systematic review and meta-analysis. Arch Dis Child. 2009 Feb;94(2):83-91. doi: 10.1136/adc.2008.141192. Epub 2008 Aug 6. |
| 19336367 | Background | Wijga AH, Scholtens S, Wieringa MH, Kerkhof M, Gerritsen J, Brunekreef B, Smit HA. Adenotonsillectomy and the development of overweight. Pediatrics. 2009 Apr;123(4):1095-101. doi: 10.1542/peds.2008-1502. |
| 23018902 | Background | Villa MP, Paolino MC, Castaldo R, Vanacore N, Rizzoli A, Miano S, Del Pozzo M, Montesano M. Sleep clinical record: an aid to rapid and accurate diagnosis of paediatric sleep disordered breathing. Eur Respir J. 2013 Jun;41(6):1355-61. doi: 10.1183/09031936.00215411. Epub 2012 Sep 27. |
| 10733617 | Background | Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x. |
| 15342852 | Background | Melendres MC, Lutz JM, Rubin ED, Marcus CL. Daytime sleepiness and hyperactivity in children with suspected sleep-disordered breathing. Pediatrics. 2004 Sep;114(3):768-75. doi: 10.1542/peds.2004-0730. |
| 16904463 | Background | Alexopoulos EI, Kostadima E, Pagonari I, Zintzaras E, Gourgoulianis K, Kaditis AG. Association between primary nocturnal enuresis and habitual snoring in children. Urology. 2006 Aug;68(2):406-9. doi: 10.1016/j.urology.2006.02.021. |
| 10889473 | Background | Franco RA Jr, Rosenfeld RM, Rao M. First place--resident clinical science award 1999. Quality of life for children with obstructive sleep apnea. Otolaryngol Head Neck Surg. 2000 Jul;123(1 Pt 1):9-16. doi: 10.1067/mhn.2000.105254. |
| 18383115 | Background | Constantin E, McGregor CD, Cote V, Brouillette RT. Pulse rate and pulse rate variability decrease after adenotonsillectomy for obstructive sleep apnea. Pediatr Pulmonol. 2008 May;43(5):498-504. doi: 10.1002/ppul.20811. |
| 2685730 | Background | Brodsky L. Modern assessment of tonsils and adenoids. Pediatr Clin North Am. 1989 Dec;36(6):1551-69. doi: 10.1016/s0031-3955(16)36806-7. |
| 31270970 | Derived | Papadakis CE, Chaidas K, Chimona TS, Zisoglou M, Ladias A, Proimos EK, Miligkos M, Kaditis AG. Assessing the need for adenotonsillectomy for sleep-disordered breathing in a community setting: A secondary outcome measures analysis of a randomized controlled study. Pediatr Pulmonol. 2019 Oct;54(10):1527-1533. doi: 10.1002/ppul.24427. Epub 2019 Jul 3. |
| 30087199 | Derived | Papadakis CE, Chaidas K, Chimona TS, Asimakopoulou P, Ladias A, Proimos EK, Miligkos M, Kaditis AG. Use of Oximetry to Determine Need for Adenotonsillectomy for Sleep-Disordered Breathing. Pediatrics. 2018 Sep;142(3):e20173382. doi: 10.1542/peds.2017-3382. Epub 2018 Aug 7. |
No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AT (Adenotonsillectomy) Group | Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB. |
| BG001 | Control Group | No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Tonsillar size 3+ | Brodsky score Upon inspection of the oropharynx grade 1 indicates that the tonsils are hidden in the pillars grade 2 indicates that the tonsils are beyond the anterior pillar and occupy between 25 and 50% of the pharyngeal space grade 3 indicates that the tonsils are beyond the pillars but not to the middle and occupy >50% and up to 75% of the pharyngeal space grade 4 indicates that the tonsils occupy >75% of the pharyngeal space | Count of Participants | Participants |
| |||||||||||||||
| Tonsillar size 4+ | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index z-score | The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population, | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Obese | Count of Participants | Participants |
| ||||||||||||||||
| Overweight or obese | Count of Participants | Participants |
| ||||||||||||||||
| Failure to thrive | Body mass index (BMI) z-score <-1.645 The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population, | Count of Participants | Participants |
| |||||||||||||||
| OSA-18 total score | OSA-18 questionnaire is a disease-specific QOL instrument for pediatric OSA. Caregivers are inquired in five domains (18 questions): sleep disturbance, physical symptoms, emotional symptoms, daytime function, and caregiver concerns. A score ranging from one to seven is assigned to each OSA-18 item, in which ''1'' corresponds to ''never'' and ''7'' to ''always''. OSA-18 values range from 18 to 126. Higher score corresponds to worse quality of life. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Number of Subjects Without Oxygenation Abnormalities | Change in number of participants with a McGill oximetry score =1 (usual oxygen saturation of hemoglobin-SpO2>95%; fewer than 3 drops below 90%; and fewer than 3 clusters of desaturation events) between 3 months and 0 months. McGill oximetry score=1: normal or inconclusive nocturnal oximetry; McGill oximetry score=2: mild hypoxemia; McGill oximetry score=3: moderate hypoxemia; McGill oximetry score=4: severe hypoxemia. | Subjects with a McGill oximetry score =1 or with a McGill oximetry score >1 | Posted | Count of Participants | Participants | 3 months (follow-up), 0 months (baseline) |
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| Primary | Change in Number of Subjects Without Oxygenation Abnormalities | Number of subjects who achieved a desaturation index (≥3% drop) of <2 episodes/h at 3 months (follow-up), if they had a desaturation index of ≥ 3.5 episodes/h at 0 months (baseline) | Subjects with a desaturation index of ≥ 3.5 episodes/h at 0 months (baseline) | Posted | Count of Participants | Participants | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Symptoms Predicting Obstructive Sleep Apnea (OSA) | Change in Pediatric Sleep Questionnaire sleep-related breathing disorder (PSQ-SRBD) scale, between follow-up and baseline. PSQ-SRBD scale ranges between 0 and 1. PSQ-SRBD score <0.33 is associated with low risk of apnea-hypopnea index >5 episodes/h; PSQ-SRBD score >=0.33 is associated with high risk of apnea-hypopnea index >5 episodes/h. | Posted | Mean | Standard Deviation | score on a scale | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Quality of Life (OSA-18 Score) | Change in obstructive sleep apnea (OSA)-18 total score between follow-up and baseline. OSA-18 is a quality of life survey including 18 questions on sleep disturbance, physical symptoms, emotional symptoms, daytime function and caregiver concerns. It is used to assess the impact of obstructive sleep apnea on child's life. Scores less than 60 suggest a small impact, between 60 and 80 moderate impact and above 80 a large impact. OSA-18 score ranges between 18 and 126. | Posted | Mean | Standard Deviation | score on a scale | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Sleepiness | Change in Modified Epworth Sleepiness Scale between follow-up and baseline Modified Epworth Sleepiness Scale ranges from 0 to 24; higher score indicates more daytime sleepiness. | Posted | Mean | Standard Deviation | score on a scale | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Somatic Growth-1 | Percent of subjects achieving an increase in weight z-score of at least 0.5. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. | Posted | Count of Participants | Participants | 0 months (baseline), 3 months (follow-up) |
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| Secondary | Somatic Growth-2 | Percent of subjects achieving an increase in body mass index z-score of at least 0.5. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population, | Posted | Count of Participants | Participants | 0 months (baseline), 3 months (follow-up) |
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| Secondary | Enuresis | Percent of subjects who achieved frequency of nocturnal enuresis < 1 night per week at follow-up (3 months), if they had incontinence at least 1 night per week at baseline (0 months). | 24 of 68 participants in the AT group and 22 of 72 participants in the control group had nocturnal enuresis at baseline. | Posted | Count of Participants | Participants | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Cardiovascular Effects-1 | Change in mean pulse rate between follow-up and baseline. | Posted | Median | Inter-Quartile Range | beats per minute | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Cardiovascular Effects-2 | Change in mean frequency of pulse rate rises (at least 6 beats per min) between follow-up and baseline. | Posted | Median | Inter-Quartile Range | pulse rate rises per hour | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Cardiovascular Effects-3 | Change in morning systolic blood pressure z-score between follow-up and baseline. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population, | Posted | Median | Inter-Quartile Range | z score | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Cardiovascular Effects-4 | Change in morning diastolic blood pressure z-score between follow-up and baseline. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population, | Posted | Median | Inter-Quartile Range | z score | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Systemic Inflammation | Change in morning serum C-reactive protein concentration between follow-up and baseline. | Posted | Median | Inter-Quartile Range | mg/dL | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Improvement in Baseline SpO2 | Proportion of subjects who had an increase from baseline in SpO2 of >1.6% | Posted | Count of Participants | Participants | 3 months (follow-up), 0 months (baseline) |
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| Secondary | Behavioral Abnormalities-1 | Change in the DuPaul Questionnaire for Parents score between follow-up and baseline. | Not Posted | 3 months (follow-up), 0 months (baseline) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Behavioral Abnormalities-2 | Change in the Achenbach Questionnaire for Parents score between follow-up and baseline. | Not Posted | 3 months (follow-up), 0 months (baseline) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effects on Sympathetic Nervous System Activation | Change in ratio of morning urine norepinephrine concentration to urine creatinine concentration between follow-up and baseline. | Not Posted | 3 months (follow-up), 0 months (baseline) | Participants |
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AT (Adenotonsillectomy) Group | Group underwent AT (adenotonsillectomy) immediately after the baseline nocturnal oximetry evaluation. Adenotonsillectomy (AT): Standard surgical intervention for treatment of Obstructive SDB. | 0 | 68 | 0 | 68 | 0 | 68 |
| EG001 | Control Group | No AT (adenotonsillectomy) for 3 months after the baseline nocturnal oximetry evaluation. | 0 | 72 | 0 | 72 | 0 | 72 |
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Oximetry was performed in-hospital and not at patients' homes.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Athanasios Kaditis, Head, Division of Pediatric Pulmonology, First Department of Pediatrics | National and Kapodistrian University of Athens School of Medicine and Aghia Sophia Children's Hospital, Athens, Greece | +302132013000 | akaditis@med.uoa.gr |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000233 | Adenoidectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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