Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918007
• Other study ID #: CHANIA-ENT-01
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: August 2016

Study information

• Verified date: August 2020
• Source: Chania General Hospital "St. George"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• Diagnosed with obstructive SDB (snoring >3 nights/week over the last 6 months)
• Tonsillar size >2 [Brodsky 1989]
• Considered as an AT candidate during the clinic visit by ear, nose and throat (ENT) surgeon

Exclusion Criteria:

• Recurrent tonsillitis defined as at least 3 episodes in each of the last 3 years or at least 5 episodes in each of the last 2 years or at least 7 episodes in the past year.
• Apparent craniofacial anomalies (e.g. Crouzon syndrome or Pierre-Robin sequence)
• Obstructive breathing while awake or any other clinical signs that merit prompt AT as recommended by the treating ENT physician.
• History of clinically important cardiovascular disease or cardiac arrhythmia.
• History of: sickle cell disease; symptomatic asthma; epilepsy; use of sedative medication
• History of: genetic disorders; neurological or neuromuscular disorders
• Use of: systemic or intranasal corticosteroids; montelukast Footnote 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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Obstructive Sleep Disordered Breathing
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing
• Snoring

Intervention

Procedure:
• Adenotonsillectomy (AT)
Standard surgical intervention for treatment of obstructive sleep-disordered (SDB).

Locations

Country	Name	City	State
Greece	Aghia Sophia Children's Hospital of Athens	Athens
Greece	Chania General Hospital "St. George"	Chania

Sponsors (2)

Lead Sponsor	Collaborator
Chania General Hospital "St. George"	Aghia Sophia Children's Hospital of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 months (follow-up), 0 months (baseline)
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)	3 months (follow-up), 0 months (baseline)
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.	3 months (follow-up), 0 months (baseline)
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.	3 months (follow-up), 0 months (baseline)
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.	3 months (follow-up), 0 months (baseline)
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.	0 months (baseline), 3 months (follow-up)
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,	0 months (baseline), 3 months (follow-up)
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).	3 months (follow-up), 0 months (baseline)
Secondary	Cardiovascular Effects-1	Change in mean pulse rate between follow-up and baseline.	3 months (follow-up), 0 months (baseline)
Secondary	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)
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,	3 months (follow-up), 0 months (baseline)
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,	3 months (follow-up), 0 months (baseline)
Secondary	Systemic Inflammation	Change in morning serum C-reactive protein concentration between follow-up and baseline.	3 months (follow-up), 0 months (baseline)
Secondary	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)
Secondary	Behavioral Abnormalities-1	Change in the DuPaul Questionnaire for Parents score between follow-up and baseline.	3 months (follow-up), 0 months (baseline)
Secondary	Behavioral Abnormalities-2	Change in the Achenbach Questionnaire for Parents score between follow-up and baseline.	3 months (follow-up), 0 months (baseline)
Secondary	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)