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

Not Applicable

Completed

• Conditions: Positional Sleep Apnea; Mandibular Advancement Device
• Interventions: Device: Sleep Position Trainer (SPT)

• Registration Number: NCT01535521
• Lead Sponsor: Ethisch Comité UZ Antwerpen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Primary Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SPT in patients with MAD	Sleep Position Trainer (SPT)	-

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium