Treatment of Children With Obstructive Sleep Apnoea and Laryngomalacia: The Role of Laser Supraglottoplasty

This is a research study of the effect of treating laryngomalacia (floppiness of tissue on top of the voice box that can possibly block breathing) found in association with obstructive sleep apnoea (blockage of breathing while sleeping). The purpose of this study is to determine which is the best treatment for children with obstructive sleep apnoea and laryngomalacia: adenotonsillectomy alone or adenotonsillectomy with laser supraglottoplasty (removal of tissue on top of the voice box to open the airway).

Official Title

Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty.

Conditions

• Sleep Apnoea, Obstructive
• Respiration Disorders

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

• As measured by overnight polysomnogram
  [Time Frame: within one year of operation]
  [Designated as safety issue: No]
• Changes in minimum oxygen saturation
  [Time Frame: within one year of operation]
  [Designated as safety issue: No]
• Changes in Respiratory Disturbance index
  [Time Frame: within one year of operation]
  [Designated as safety issue: No]
• Changes in peak end-tidal carbon dioxide(CO2) level
  [Time Frame: within one year of operation]
  [Designated as safety issue: No]
• Changes in mean end-tidal carbon dioxide(CO2) level
  [Time Frame: within one year of operation]
  [Designated as safety issue: No]

Secondary Outcome Measures:

• Overall category of airway obstruction on polysomnogram (e.g. normal, mild, moderate, severe obstructive sleep apnoea)
  [Time Frame: within one year of operation]
  [Designated as safety issue: No]

Study Start

January 2002

Eligibility & Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 1 year old to 18 years of age
• Clinical signs or symptoms of obstructive sleep apnoea (snoring, witnessed apneas, daytime somnolence, restless sleeping, or cyanosis)
• Abnormal polysomnogram (mild, moderate, or severe OSA) including CO₂ measures, failed or refused trial of CPAP, or not recommended by their pulmonologist or primary care doctor.

Exclusion Criteria:

• Prior laser supraglottoplasty
• Prior adenoidectomy prior tonsillectomy
• Stridor with cyanosis or apnoea
• Severe respiratory distress
• Recurrent pneumonia (x3)
• Laryngeal cyst
• Vocal cord (VC) Paralysis
• Airway vascular malformation
• Neoplasm
• Subglottic haemangioma
• Paradoxical vocal cord (VC) motion
• Posterior glottic stenosis
• Glottic webs
• Discoordinate pharyngolaryngomalacia
• Refusal to participate

Total Enrolment

757

Contact Details

Shelley Bizila
317-274-8289
resrisk@iupui.edu

Location:

Riley Childrens’ Hospital
Indianapolis, Indiana
United States, 46202