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NCT03760341

Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients

Completed NA Last updated 17 September 2019
What this trial tests

NA trial testing adenoidectomy - cold method in Obstructive Sleep Apnea in 80 participants. Completed in 20 March 2019.

Timeline
1 October 2014
Primary endpoint
30 August 2018
20 March 2019

Quick facts

Lead sponsorRambam Health Care Campus
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment80
Start date1 October 2014
Primary completion30 August 2018
Estimated completion20 March 2019

Drugs / interventions tested

Conditions studied

Sponsor

Rambam Health Care Campus — full company profile →

Who can join

Adults 1 to 15, any sex, with Obstructive Sleep Apnea or Adenoid; Growth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Adenoidectomy is one of the most common procedures done by the otolaryngologist. The procedure can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and post-operative outcomes. However, the long term clinical outcome in improving the sleep disorder symptoms was never compared between the two methods. Objective: To compare the advantages using the hot method compared to the cold method adenoidectomy in the long term follow up. Methods: A prospective, randomized, single blinded study of children undergoing adenoidectomy between the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques. The primary outcome was change of the Pediatric Sleep Questionnaire Score (PSQ) scores one month and one year after surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

Other Rambam Health Care Campus trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03760341.

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