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

Ethisch Comité UZ Antwerpen

Status: Completed

Conditions: Positional Sleep Apnea; Mandibular Advancement Device

Treatments: Device: Sleep Position Trainer (SPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01535521

SupPos

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

SPT in patients with MAD

Other group

Treatment:

Device: Sleep Position Trainer (SPT)