Trial record 7 of 1413 for:    "Sleep Disorders, Intrinsic"

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

This study is currently recruiting participants.
Verified August 2013 by Chania General Hospital ”St. George”
Sponsor:
Collaborator:
Aghia Sophia Children's Hospital of Athens
Information provided by (Responsible Party):
Chania General Hospital ”St. George”
ClinicalTrials.gov Identifier:
NCT01918007
First received: July 26, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Sleep Disordered Breathing
Obstructive Sleep Apnea
Adenotonsillectomy
Snoring
Obstructive Sleep Disordered Breathing
Procedure: Adenotonsillectomy (AT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study

Resource links provided by NLM:


Further study details as provided by Chania General Hospital ”St. George”:

Primary Outcome Measures:
  • Change in proportion of subjects without oxygenation abnormalities [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    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.

  • Proportion of subjects with oxygenation abnormalities at baseline who improved at follow-up [ Time Frame: 3 months (follow-up) ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Somatic growth [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Percent of subjects achieving an increase in weight z-score or in body mass index z-score of at least 0.5.

  • Abnormalities predisposing to obstructive sleep apnea (OSA) and OSA symptoms [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Change in the Sleep Clinical Record score and change in Pediatric Sleep Questionnaire score, between follow-up and baseline.

  • Sleepiness [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Change in Modified Epworth Sleepiness Scale between follow-up and baseline.

  • Behavioral abnormalities-1 [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Change in the DuPaul Questionnaire for Parents score between follow-up and baseline.

  • Behavioral abnormalities-2 [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Change in the Achenbach Questionnaire for Parents score between follow-up and baseline.

  • Enuresis [ Time Frame: 3 months (follow-up) ] [ Designated as safety issue: No ]
    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).

  • Quality of life [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Change in obstructive sleep apnea syndrome (OSAS)-18 (total score) between follow-up and baseline.

  • Cardiovascular effects-1 [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Changes in mean pulse rate and mean frequency of pulse rate rises between follow-up and baseline.

  • Cardiovascular effects-2 [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Change in morning systolic and diastolic blood pressure z-score between follow-up and baseline.

  • Systemic inflammation [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Change in morning serum C-reactive protein between follow-up and baseline.

  • Effects on sympathetic nervous system activation [ Time Frame: 0 months (baseline), 3 months (follow-up) ] [ Designated as safety issue: No ]
    Change in morning urine norepinephrine-corrected for urine creatinine- between follow-up and baseline.


Estimated Enrollment: 160
Study Start Date: June 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Removal of adenoids and tonsils
No Intervention: Control Group
No AT (adenotonsillectomy) for 3 months after the baseline study evaluation

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.

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Piere-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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918007

Contacts
Contact: Athanasios G Kaditis, MD +30-6948530256 kaditia@hotmail.com

Locations
Greece
Aghia Sophia Children's Hospital of Athens Active, not recruiting
Athens, Greece, 11527
Chania General Hospital "St. George" Recruiting
Chania, Greece, 73300
Contact: Chariton Papadakis, MD    +306944468261    chpap@hotmail.com   
Principal Investigator: Chariton Papadakis, MD         
Principal Investigator: Theognosia S. Chimona, MD         
Principal Investigator: Panagiota N. Asimakopoulou, MD         
Principal Investigator: Efklidis Proimos, MD         
Sponsors and Collaborators
Chania General Hospital ”St. George”
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
  More Information

Publications:

Responsible Party: Chania General Hospital ”St. George”
ClinicalTrials.gov Identifier: NCT01918007     History of Changes
Other Study ID Numbers: CHANIA-ENT-01
Study First Received: July 26, 2013
Last Updated: August 5, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Chania General Hospital ”St. George”:
Sleep Disorders, Intrinsic
Apnea
Sleep Apnea Syndromes
Snoring
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory Signs and Symptoms
Dyssomnias
Sleep Disorders
Respiratory Sounds

Additional relevant MeSH terms:
Sleep Disorders, Intrinsic
Apnea
Respiratory Aspiration
Sleep Apnea Syndromes
Snoring
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Sleep Disorders
Nervous System Diseases
Respiratory Sounds

ClinicalTrials.gov processed this record on April 17, 2014