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CompletedNCT01918007Updated Nov 13, 2023Results posted

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

An interventional study of Adenotonsillectomy (AT) in Sleep Disordered Breathing, Obstructive Sleep Apnea and Snoring, sponsored by Chania General Hospital "St. George". Completed at 2 sites in Greece. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2023-11-13.

Primary conditionSleep Apnea, ObstructiveRegistry: Sleep Apnea SyndromesReclassifiedWhy we changed it
Registry
Sleep Apnea Syndromes — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sleep Apnea, Obstructive
Why
  1. The study's listed conditions name Sleep Apnea, Obstructive, a narrower term within Sleep Apnea Syndromes.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Chania General Hospital "St. George" · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Sleep Disordered Breathing
  • Obstructive Sleep Apnea
  • Snoring
  • Obstructive Sleep Disordered Breathing

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
03

In context

Sleep Apnea, Obstructive Reclassified

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's enrollment of 186 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Chania General Hospital "St. George" is the lead sponsor of 3 studies on the registry; none are open to participants now.

Compared within Sleep Apnea, Obstructive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sleep Apnea Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 ; 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
186 participants (actual)

Study arms

  • Active comparator
    AT (adenotonsillectomy) Group

    AT (adenotonsillectomy) immediately after the baseline study evaluation

    Procedure: Adenotonsillectomy (AT)

  • No intervention
    Control Group

    No AT (adenotonsillectomy) for 3 months after the baseline study evaluation

Interventions

  • ProcedureAdenotonsillectomy (AT)

    Standard surgical intervention for treatment of obstructive sleep-disordered (SDB).

    Also known as: Removal of adenoids and tonsils

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months (follow-up), 0 months (baseline)

  2. 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)

    Time frame: 3 months (follow-up), 0 months (baseline)

Secondary outcomes

  1. 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.

    Time frame: 3 months (follow-up), 0 months (baseline)

  2. 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.

    Time frame: 3 months (follow-up), 0 months (baseline)

  3. 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.

    Time frame: 3 months (follow-up), 0 months (baseline)

  4. 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.

    Time frame: 0 months (baseline), 3 months (follow-up)

  5. 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,

    Time frame: 0 months (baseline), 3 months (follow-up)

  6. 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).

    Time frame: 3 months (follow-up), 0 months (baseline)

  7. Cardiovascular Effects-1

    Change in mean pulse rate between follow-up and baseline.

    Time frame: 3 months (follow-up), 0 months (baseline)

  8. Cardiovascular Effects-2

    Change in mean frequency of pulse rate rises (at least 6 beats per min) between follow-up and baseline.

    Time frame: 3 months (follow-up), 0 months (baseline)

  9. 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,

    Time frame: 3 months (follow-up), 0 months (baseline)

  10. 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,

    Time frame: 3 months (follow-up), 0 months (baseline)

  11. Systemic Inflammation

    Change in morning serum C-reactive protein concentration between follow-up and baseline.

    Time frame: 3 months (follow-up), 0 months (baseline)

  12. Improvement in Baseline SpO2

    Proportion of subjects who had an increase from baseline in SpO2 of \>1.6%

    Time frame: 3 months (follow-up), 0 months (baseline)

  13. Behavioral Abnormalities-1

    Change in the DuPaul Questionnaire for Parents score between follow-up and baseline.

    Time frame: 3 months (follow-up), 0 months (baseline)

  14. Behavioral Abnormalities-2

    Change in the Achenbach Questionnaire for Parents score between follow-up and baseline.

    Time frame: 3 months (follow-up), 0 months (baseline)

  15. Effects on Sympathetic Nervous System Activation

    Change in ratio of morning urine norepinephrine concentration to urine creatinine concentration between follow-up and baseline.

    Time frame: 3 months (follow-up), 0 months (baseline)

07

Results

Posted Nov 13, 2023
Limitations and caveats
Oximetry was performed in-hospital and not at patients' homes.

Participant flow

Recruitment between June 2013 and April 2016; ENT Clinic of a Regional Hospital in Greece (Chania, Crete).

Participant flow — Overall Study
MilestoneAT (Adenotonsillectomy) GroupControl Group
Started9393
Completed6872
Not completed2521
Withdrew: Baseline oximetry not acceptable117
Withdrew: Follow-up oximetry not acceptable107
Withdrew: Lost to follow-up47

Outcome measures

PrimaryChange 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.

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Count of participants · Participants
Change in Number of Subjects Without Oxygenation Abnormalities
ParticipantsAT (Adenotonsillectomy) GroupControl Group
Change in Number of Subjects Without Oxygenation Abnormalities1210
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Chi-squared · p = 0.54 · Odds ratio (or): 1.3 · 95% CI 0.5 to 3.3
PrimaryChange 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)

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Count of participants · Participants
Change in Number of Subjects Without Oxygenation Abnormalities
ParticipantsAT (Adenotonsillectomy) GroupControl Group
Change in Number of Subjects Without Oxygenation Abnormalities142
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Chi-squared · p = <0.001 · Odds ratio (or): 14 · 95% CI 2.9 to 68.4
SecondarySymptoms 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.

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Mean · score on a scale
Symptoms Predicting Obstructive Sleep Apnea (OSA)
score on a scaleAT (Adenotonsillectomy) GroupControl Group
Symptoms Predicting Obstructive Sleep Apnea (OSA)-0.32 ± 0.15-0.01 ± 0.09
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · t-test, 2 sided · p = <0.001 · Mean difference (net): -0.31 · 95% CI -0.35 to -0.27
SecondaryQuality 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.

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Mean · score on a scale
Quality of Life (OSA-18 Score)
score on a scaleAT (Adenotonsillectomy) GroupControl Group
Quality of Life (OSA-18 Score)-32.4 ± 16.9-0.8 ± 9.1
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · t-test, 2 sided · p = <0.001
SecondarySleepiness

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.

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Mean · score on a scale
Sleepiness
score on a scaleAT (Adenotonsillectomy) GroupControl Group
Sleepiness-2.75 ± 3.070.01 ± 2.04
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · t-test, 2 sided · p = <0.001 · Mean difference (net): -2.76 · 95% CI -3.63 to -1.90
SecondarySomatic 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.

Time frame:
0 months (baseline), 3 months (follow-up)
Reported as:
Count of participants · Participants
Somatic Growth-1
ParticipantsAT (Adenotonsillectomy) GroupControl Group
Somatic Growth-12321
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Chi-squared · p = 0.553 · Risk ratio (rr): 1.16 · 95% CI 0.71 to 1.89
SecondarySomatic 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,

Time frame:
0 months (baseline), 3 months (follow-up)
Reported as:
Count of participants · Participants
Somatic Growth-2
ParticipantsAT (Adenotonsillectomy) GroupControl Group
Somatic Growth-22213
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Chi-squared · p = 0.057 · Risk ratio (rr): 1.79 · 95% CI 0.98 to 3.27
SecondaryEnuresis

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).

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Count of participants · Participants
Enuresis
ParticipantsAT (Adenotonsillectomy) GroupControl Group
Enuresis104
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Chi-squared · p = 0.084 · Risk ratio (rr): 2.29 · 95% CI 0.84 to 6.25
SecondaryCardiovascular Effects-1

Change in mean pulse rate between follow-up and baseline.

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Median · beats per minute
Cardiovascular Effects-1
beats per minuteAT (Adenotonsillectomy) GroupControl Group
Cardiovascular Effects-1-0.1 (-6.3 to 5.2)-0.9 (-4.9 to 2.7)
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Wilcoxon (Mann-Whitney) · p = 0.547
SecondaryCardiovascular Effects-2

Change in mean frequency of pulse rate rises (at least 6 beats per min) between follow-up and baseline.

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Median · pulse rate rises per hour
Cardiovascular Effects-2
pulse rate rises per hourAT (Adenotonsillectomy) GroupControl Group
Cardiovascular Effects-2-1.2 (-7.6 to 1.1)-0.1 (-4.6 to 3.8)
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Wilcoxon (Mann-Whitney) · p = 0.062
SecondaryCardiovascular 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,

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Median · z score
Cardiovascular Effects-3
z scoreAT (Adenotonsillectomy) GroupControl Group
Cardiovascular Effects-30.5 (-8 to 10.8)-2 (-22 to 13)
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Wilcoxon (Mann-Whitney) · p = 0.208
SecondaryCardiovascular 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,

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Median · z score
Cardiovascular Effects-4
z scoreAT (Adenotonsillectomy) GroupControl Group
Cardiovascular Effects-4-1 (-22.3 to 14.5)-6 (-22 to 13)
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Wilcoxon (Mann-Whitney) · p = 0.585
SecondarySystemic Inflammation

Change in morning serum C-reactive protein concentration between follow-up and baseline.

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Median · mg/dL
Systemic Inflammation
mg/dLAT (Adenotonsillectomy) GroupControl Group
Systemic Inflammation0 (0 to 0.07)0 (-0.17 to 0.07)
Statistical analysis
  • AT (Adenotonsillectomy) Group vs Control Group · Wilcoxon (Mann-Whitney) · p = 0.074
SecondaryImprovement in Baseline SpO2

Proportion of subjects who had an increase from baseline in SpO2 of \>1.6%

Time frame:
3 months (follow-up), 0 months (baseline)
Reported as:
Count of participants · Participants
Improvement in Baseline SpO2
ParticipantsAT (Adenotonsillectomy) GroupControl Group
Improvement in Baseline SpO267
SecondaryBehavioral Abnormalities-1

Change in the DuPaul Questionnaire for Parents score between follow-up and baseline.

Time frame:
3 months (follow-up), 0 months (baseline)

Results for this outcome have not been posted.

SecondaryBehavioral Abnormalities-2

Change in the Achenbach Questionnaire for Parents score between follow-up and baseline.

Time frame:
3 months (follow-up), 0 months (baseline)

Results for this outcome have not been posted.

SecondaryEffects on Sympathetic Nervous System Activation

Change in ratio of morning urine norepinephrine concentration to urine creatinine concentration between follow-up and baseline.

Time frame:
3 months (follow-up), 0 months (baseline)

Results for this outcome have not been posted.

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AT (Adenotonsillectomy) Group0/68 (0%)0/68 (0%)0/68 (0%)
Control Group0/72 (0%)0/72 (0%)0/72 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)AT (Adenotonsillectomy) GroupControl GroupTotal
Mean5.9 ± 1.66 ± 1.66 ± 1.6
Sex: Female, Male
Sex: Female, Male(Participants)AT (Adenotonsillectomy) GroupControl GroupTotal
Female333467
Male353873
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)AT (Adenotonsillectomy) GroupControl GroupTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)AT (Adenotonsillectomy) GroupControl GroupTotal
Greece6872140
Tonsillar size 3+
Tonsillar size 3+(Participants)AT (Adenotonsillectomy) GroupControl GroupTotal
Count of participants6165126
Tonsillar size 4+
Tonsillar size 4+(Participants)AT (Adenotonsillectomy) GroupControl GroupTotal
Count of participants7714
Body mass index z-score
Body mass index z-score(units on a scale)AT (Adenotonsillectomy) GroupControl GroupTotal
Mean0.3 ± 1.40.2 ± 1.60.2 ± 1.5
Obese
Obese(Participants)AT (Adenotonsillectomy) GroupControl GroupTotal
Count of participants121426

3 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Aghia Sophia Children's Hospital of Athens
    Athens, 11527, Greece
  • Chania General Hospital "St. George"
    Chania, 73300, Greece
09

References and documents

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 14702490 ↗
  • 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. PubMed 16997385 ↗
  • 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. PubMed 18684748 ↗
  • 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. PubMed 19336367 ↗
  • 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. PubMed 23018902 ↗
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  • 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. PubMed 15342852 ↗
  • 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. PubMed 16904463 ↗
  • 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. PubMed 10889473 ↗
  • 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. PubMed 18383115 ↗
  • 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. PubMed 2685730 ↗
  • 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. PubMed 31270970 ↗
  • 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. PubMed 30087199 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013, a primary completion of Apr 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Nov 2023, 7 years 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2013
First posted
Aug 7, 2013
Start
Jun 2013
Primary completionActual
Apr 2016
CompletionActual
Aug 2016
Results first posted
Nov 13, 2023
Last update
Nov 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01918007
Lead sponsor
Chania General Hospital "St. George"
Collaborators
Aghia Sophia Children's Hospital of Athens
Responsible party
Sponsor
First posted
Aug 7, 2013
Start date
Jun 2013
Primary completion
Apr 2016
Completion
Aug 2016
Results posted
Nov 13, 2023
Last update
Nov 13, 2023

Study contacts

Chariton E. Papadakis, MD
study director · Chania General Hospital "St. George"
Athanasios G. Kaditis, MD
study chair · Aghia Sophia Children's Hospital of Athens
Theognosia 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 Athens
Alexandra Klimentopoulou, MD
principal investigator · Aghia Sophia Children's Hospital of Athens

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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