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

NCT ID: NCT01535521

Last Updated: 2013-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Positional Sleep Apnea Mandibular Advancement Device

Study Groups

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SPT in patients with MAD

Group Type OTHER

Sleep Position Trainer (SPT)

Intervention Type DEVICE

Interventions

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Sleep Position Trainer (SPT)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethisch Comité UZ Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Ethisch Comité UZ Antwerpen

Dr. Olivier M. Vanderveken (principal investigator)

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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Dieltjens M, Vroegop AV, Verbruggen AE, Wouters K, Willemen M, De Backer WA, Verbraecken JA, Van de Heyning PH, Braem MJ, de Vries N, Vanderveken OM. A promising concept of combination therapy for positional obstructive sleep apnea. Sleep Breath. 2015 May;19(2):637-44. doi: 10.1007/s11325-014-1068-8. Epub 2014 Oct 22.

Reference Type DERIVED
PMID: 25335642 (View on PubMed)

Other Identifiers

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SupPos

Identifier Type: -

Identifier Source: org_study_id

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