Sleep Positional Trainer for Positional Sleep Apnea After... | NCT01535521

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

NCT01535521

Sponsor

Ethisch Comité UZ Antwerpen

Status

Completed

Last Update Posted

Jun 20, 2013Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Positional Sleep Apnea
Mandibular Advancement Device

Interventions

Sleep Position Trainer (SPT)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Feb 2013Actual

Completion Date

Not provided

First Submitted Date

Feb 14, 2012

First Submission Date that Met QC Criteria

Feb 16, 2012

First Posted Date

Feb 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2013

Last Update Posted Date

Jun 20, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ethisch Comité UZ Antwerpen, Dr. Olivier M. Vanderveken (principal investigator), University Hospital, AntwerpSponsor-Investigator

Lead Sponsor

Ethisch Comité UZ AntwerpenOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
SPT in patients with MAD	Other		Device: Sleep Position Trainer (SPT)

Name	Type	Description	Arm Group Labels	Other Names
Sleep Position Trainer (SPT)	Device		SPT in patients with MAD

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital		Edegem	Antwerp	2650	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25335642	Derived	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.