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

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ClinicalTrials.gov Identifier: NCT01535521
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : June 20, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Positional Sleep Apnea Mandibular Advancement Device Device: Sleep Position Trainer (SPT)

Study Design

Study Type : Interventional  (Clinical Trial)
Official Title: Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)
Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
SPT in patients with MAD Device: Sleep Position Trainer (SPT)

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535521

Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Ethisch Comité UZ Antwerpen
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ethisch Comité UZ Antwerpen, Dr. Olivier M. Vanderveken (principal investigator), University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01535521     History of Changes
Other Study ID Numbers: SupPos
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases