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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535521
First Posted: February 17, 2012
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
  Purpose
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 Intervention
Positional Sleep Apnea Mandibular Advancement Device Device: Sleep Position Trainer (SPT)

Study Type: Interventional
Official Title: Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)

Resource links provided by NLM:


Further study details as provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:

Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SPT in patients with MAD Device: Sleep Position Trainer (SPT)

  Eligibility

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
Criteria

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


Locations
Belgium
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 Submitted: February 14, 2012
First Posted: February 17, 2012
Last Update Posted: June 20, 2013
Last Verified: June 2013

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