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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01535521
First received: February 14, 2012
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  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:

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

Further study details as provided by University Hospital, Antwerp:

Arms Assigned Interventions
SPT in patients with MAD Device: Sleep Position Trainer (SPT)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535521

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

No publications provided

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
Study First Received: February 14, 2012
Last Updated: February 27, 2012
Health Authority: Belgium: Ethics Committee

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013