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

Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01535521
Acronym
SupPos
Enrollment
Unknown
Registered
2012-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Advancement Device, Positional Sleep Apnea

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.

Interventions

DEVICESleep Position Trainer (SPT)

Sponsors

Ethisch Comité UZ Antwerpen
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026