NCT01535521

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

First QC Date

February 14, 2012

Last Update Submit

June 19, 2013

Conditions

Positional Sleep ApneaMandibular Advancement Device

Study Arms (1)

SPT in patients with MAD

OTHER
Device: Sleep Position Trainer (SPT)

Interventions

Sleep Position Trainer (SPT)DEVICE
SPT in patients with MAD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with supine dependent Obstructive Sleep Apnea (OSA) after Mandibular Advancement Device (MAD) Therapy: Apnea Hypopnea Index (AHI) supine ≥ 2x AHI non supine
  • \< 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

You may not qualify if:

  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 25335642DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Olivier M. Vanderveken (principal investigator)

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 17, 2012

Primary Completion

February 1, 2013

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

BE(1)