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Completed

NCT Number: NCT01918007

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

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.

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Key information

Conditions

Sleep Disordered Breathing Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Obstructive Sleep Apnea Obstructive Sleep Disordered Breathing Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aghia Sophia Children's Hospital of Athens, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adenotonsillectomy (AT)

Procedure

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

Other names: Removal of adenoids and tonsils

Primary outcomes

  1. Change in Number of Subjects Without Oxygenation Abnormalities

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

    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.

  2. Change in Number of Subjects Without Oxygenation Abnormalities

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

    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)

Secondary outcomes

  1. Symptoms Predicting Obstructive Sleep Apnea (OSA)

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

    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.

  2. Quality of Life (OSA-18 Score)

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

    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. Sleepiness

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

    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.

  4. Somatic Growth-1

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

    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.

  5. Somatic Growth-2

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

    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,

  6. Enuresis

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

    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).

  7. Cardiovascular Effects-1

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

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

  8. Cardiovascular Effects-2

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

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

  9. Cardiovascular Effects-3

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

    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,

  10. Cardiovascular Effects-4

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

    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,

  11. Systemic Inflammation

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

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

  12. Improvement in Baseline SpO2

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

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

  13. Behavioral Abnormalities-1

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

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

  14. Behavioral Abnormalities-2

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

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

  15. Effects on Sympathetic Nervous System Activation

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

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

Sponsors and collaborators

Lead sponsor

Chania General Hospital "St. George"

Other

Collaborators

  • Aghia Sophia Children's Hospital of Athens

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2013
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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