Efficacy of a mandibular advancement appliance on Sleep Disordered Breathing in childre

Not Applicable

• Conditions: Sleep Disordered Breathing in Chlidren; Respiratory - Sleep apnoea

• Registration Number: ACTRN12614001013651
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

SDB diagnosis.

Exclusion Criteria

severe OSA (AHI more than ten events per hour);craniofacial syndromes and genetic syndromes; neuromuscular diseases; body mass index at or above 95th percentile of normative values.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea/Hypopnea Index (AHI – primary outcome) <br>This is defined as number of apnea and hypopnea events recorded per hour of sleep. An apnea episode is defined as cessation of breathing for 10 seconds or longer. A hypopnea episode is defined as reduced respiratory airflow by 30% with a 4% decrease in oxygen saturation.<br>AHI will be assessed using the portable monitoring device. <br>[This monitoring will be carried out four times during the study at the beginning and at the end of each treatment period .];Snoring frequency and intensity <br>Snoring sounds will be assessed using the portable PSG equipment. Reports of snoring frequency and intensity will also be collected by parents using daily diaries. <br>[Snoring frequency and intensity will be assessed at the beginning and the end of each treatment period. Reports of snoring frequency and intensity will also be collected by parents using daily diaries. <br>]