CompletedNot Applicable

ATT Compared With ATE in OSAS Children

Sweden79 participantsStarted 2011-11

Plain-language summary

Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.

Who can participate

Age range2 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 2-6 years * Clinical symptoms of OSAS (apneas, snoring, disturbed sleep) * Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal space) * Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA) Exclusion Criteria: * Clinical signs of craniofacial anomalies or neuromuscular disorders * Obesity * Earlier having had surgery of tonsils or adenoid * Bleeding disorder * Cardiopulmonary disorder

What they're measuring

Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)

Timeframe: One, three and ten years

Trial details

NCT IDNCT01676181

SponsorKarolinska University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03

View on ClinicalTrials.gov More Obstructive Sleep Apnea Syndrome in Children trials