NCT01535521CompletedNot Applicable
Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)
Ethisch Comité UZ Antwerpen2 sites in 1 countryStarted: February 17, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Investigators
Ethisch Comité UZ Antwerpen
Dr. Olivier M. Vanderveken (principal investigator)
University Hospital, Antwerp
Study Sites (2)
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