Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy

Ethisch Comité UZ Antwerpen

Overview

The investigators will perform a clinical trial comparing mandibular advancement device (MAD) therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients with positional sleep apnea using MAD. Patients are invited for 2 consecutive polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD. PSGs are performed at the Antwerp University Hospital.

Study Type

INTERVENTIONAL

Conditions

Positional Sleep Apnea Mandibular Advancement Device

Interventions

Sleep Position Trainer (SPT)DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with supine dependent Obstructive Sleep Apnea (OSA) after Mandibular Advancement Device (MAD) Therapy: Apnea Hypopnea Index (AHI) supine ≥ 2x AHI non supine * 5 \< AHI \< 50/h sleep on polysomnography (PSG) with MAD in situ * ≥ 20% supine position during PSG with the MAD in situ * AHI non-supine \< 10/h en AHI supine ≥ 10/h on PSG with MAD in situ * Unchanged Body Mass Index (BMI)(BMI ± 1 kg/m²) at moment of inclusion compared to BMI at baseline PSG Exclusion Criteria: * age \< 18 years

Locations (1)

Antwerp University Hospital

Edegem, Antwerp, Belgium

Data from ClinicalTrials.gov

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