Sleep Disordered BreathingNCT01918007
Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study
A study testing Adenotonsillectomy (AT) in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Chania General Hospital "St. George" at 2 sites in Greece.
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… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Snoring
- What is being tested?
- Adenotonsillectomy (AT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesGreece
- Study dates
- Jun 2013to Aug 2016
- Phase
- Interventional
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Aghia Sophia Children's Hospital of Athens
Athens, 11527
Chania General Hospital "St. George"
Chania, 73300
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Snoring, Obstructive Sleep Disordered Breathing
- Being tested
- Adenotonsillectomy (AT)
- Keywords
- Apnea, Sleep Apnea Syndromes, Snoring, Sleep Apnea, Obstructive, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory Signs and Symptoms, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Disorders, Respiratory Sounds
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Snoring, Apnea, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Sleep Disorders, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenotonsillectomy (AT)Procedure or surgery
Also called Removal of adenoids and tonsils
Standard surgical intervention for treatment of obstructive sleep-disordered (SDB).
| Study group | Role | What they receive |
|---|---|---|
| AT (adenotonsillectomy) Group | Active comparator | AT (adenotonsillectomy) immediately after the baseline study evaluation Receives: Procedure: Adenotonsillectomy (AT) |
| Control Group | No intervention | No AT (adenotonsillectomy) for 3 months after the baseline study evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 3 months (follow-up), 0 months (baseline)
Secondary outcomes (15)
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.
Measured: 3 months (follow-up), 0 months (baseline)
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.
Measured: 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.
Measured: 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.
Measured: 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,
Measured: 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).
Measured: 3 months (follow-up), 0 months (baseline)
Cardiovascular Effects-1
Change in mean pulse rate between follow-up and baseline.
Measured: 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.
Measured: 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,
Measured: 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,
Measured: 3 months (follow-up), 0 months (baseline)
Systemic Inflammation
Change in morning serum C-reactive protein concentration between follow-up and baseline.
Measured: 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%
Measured: 3 months (follow-up), 0 months (baseline)
Behavioral Abnormalities-1
Change in the DuPaul Questionnaire for Parents score between follow-up and baseline.
Measured: 3 months (follow-up), 0 months (baseline)
Behavioral Abnormalities-2
Change in the Achenbach Questionnaire for Parents score between follow-up and baseline.
Measured: 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.
Measured: 3 months (follow-up), 0 months (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Sleep Disordered BreathingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chania General Hospital "St. George"
- Sponsor type
- University, hospital or other
- Collaborators
- Aghia Sophia Children's Hospital of Athens
- Responsible party
- Sponsor
- Investigators
- Chariton E. Papadakis, MD, Study director, Chania General Hospital "St. George"Athanasios G. Kaditis, MD, Study chair, Aghia Sophia Children's Hospital of AthensTheognosia S. Chimona, MD, Principal investigator, Chania General Hospital "St. George"Panagiota N. Asimakopoulou, MD, Principal investigator, Chania General Hospital "St. George"Efklidis Proimos, MD, Principal investigator, Chania General Hospital "St. George"Konstantinos Chaidas, MD, Principal investigator, Aghia Sophia Children's Hospital of AthensAlexandra Klimentopoulou, MD, Principal investigator, Aghia Sophia Children's Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918007
- Sponsor's protocol ID
- CHANIA-ENT-01
- Status last verified
- Aug 2020
- First submitted
- 26 Jul 2013
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 14702490Saito 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.
PubMed 16997385Bonuck 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.
PubMed 18684748Wijga 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.
PubMed 19336367Villa 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.
PubMed 23018902Chervin 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.
PubMed 10733617Melendres 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.
PubMed 15342852Alexopoulos 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.
PubMed 16904463Franco 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.
PubMed 10889473Constantin 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.
PubMed 18383115Brodsky 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.
PubMed 2685730Papadakis 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.
PubMed 31270970Papadakis 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.
PubMed 30087199