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

Primary Purpose

Positional Sleep Apnea, Mandibular Advancement Device

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sleep Position Trainer (SPT)
Sponsored by
Ethisch Comité UZ Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Positional Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SPT in patients with MAD

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2012
Last Updated
June 19, 2013
Sponsor
Ethisch Comité UZ Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT01535521
Brief Title
Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy
Acronym
SupPos
Official Title
Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ethisch Comité UZ Antwerpen

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positional Sleep Apnea, Mandibular Advancement Device

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
SPT in patients with MAD
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Sleep Position Trainer (SPT)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
25335642
Citation
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.
Results Reference
derived

Learn more about this trial

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

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