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

August 31, 2016 updated by: Chania General Hospital "St. George"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: AT (adenotonsillectomy) Group
AT (adenotonsillectomy) immediately after the baseline study evaluation
Procedure: Adenotonsillectomy (AT)
Standard surgical intervention for treatment of Obstructive SDB.
Other Names:
  • Removal of adenoids and tonsils
NO_INTERVENTION: Control Group
No AT (adenotonsillectomy) for 3 months after the baseline study evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proportion of subjects without oxygenation abnormalities
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in proportion 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.
0 months (baseline), 3 months (follow-up)
Proportion of subjects with oxygenation abnormalities at baseline who improved at follow-up
Time Frame: 3 months (follow-up)
Proportion 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Somatic growth
Time Frame: 0 months (baseline), 3 months (follow-up)
Percent of subjects achieving an increase in weight z-score or in body mass index z-score of at least 0.5.
0 months (baseline), 3 months (follow-up)
Abnormalities predisposing to obstructive sleep apnea (OSA) and OSA symptoms
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in the Sleep Clinical Record score and change in Pediatric Sleep Questionnaire score, between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Sleepiness
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in Modified Epworth Sleepiness Scale between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Behavioral abnormalities-1
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in the DuPaul Questionnaire for Parents score between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Behavioral abnormalities-2
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in the Achenbach Questionnaire for Parents score between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Enuresis
Time Frame: 3 months (follow-up)
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)
Quality of life
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in obstructive sleep apnea syndrome (OSAS)-18 (total score) between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Cardiovascular effects-1
Time Frame: 0 months (baseline), 3 months (follow-up)
Changes in mean pulse rate and mean frequency of pulse rate rises between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Cardiovascular effects-2
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in morning systolic and diastolic blood pressure z-score between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Systemic inflammation
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in morning serum C-reactive protein between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Effects on sympathetic nervous system activation
Time Frame: 0 months (baseline), 3 months (follow-up)
Change in morning urine norepinephrine-corrected for urine creatinine- between follow-up and baseline.
0 months (baseline), 3 months (follow-up)
Improvement in baseline SpO2
Time Frame: 0 months (baseline), 3 months (follow-up)
Proportion of subjects who had an increase from baseline in SpO2 of >1.6% according to baseline SpO2 level
0 months (baseline), 3 months (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chania General Hospital "St. George"

Collaborators

Aghia Sophia Children's Hospital of Athens

Investigators

  • Study Director: Chariton E. Papadakis, MD, Chania General Hospital "St. George"
  • Study Chair: Athanasios G. Kaditis, MD, Aghia Sophia Children's Hospital of Athens
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (ESTIMATE)

August 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANIA-ENT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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