NCT02320877

Brief Summary

In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep apnea (OSA) (AHI \> 15/h sleep) will be included and treated with mandibular advancement devices (MAD). These patients will undergo cardiovascular examination; echocardiography and 24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients. These cardiovascular examinations will take place before and during MAD therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

6.1 years

First QC Date

November 24, 2014

Last Update Submit

January 15, 2021

Conditions

OSA

Outcome Measures

Primary Outcomes (4)

  • cardiovascular outcome - interventricular septum thickness

    interventricular septum thickness

    1 year

  • cardiovascular outcome - ventricular dilatation

    ventricular dilatation

    1 year

  • cardiovascular outcome - cardiac strain

    cardiac strain. This will be measured on speckle tracking echocardiopgraphy (STE). STE is an echocardiographic imaging technique that analyzes the motion of heart tissue by using ultrasound waves to generate interference patterns and natural acoustic reflections. These reflections, also described as ''speckles'', are tracked consecutively frame to frame and ultimately resolved into angle-independent two-dimensional and three-dimensional strain-based sequences (3D). These sequences provide both quantitative and qualitative information regarding heart tissue deformation and motion.

    1 year

  • cardiovascular outcome - stroke volume

    stroke volume

    1 year

Secondary Outcomes (4)

  • OSA efficacy: apnea-hypopnea index

    1 year

  • Therapy compliance

    1 year

  • efficacy on subjective complaints: epworth sleepiness scale

    1 year

  • efficacy on subjective complaints: visual analogue scale for snoring

    1 year

Study Arms (1)

Mandibular Advancement Device

EXPERIMENTAL

Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway.

Device: Mandibular Advancement Device (Somnomed Flex)

Interventions

Mandibular Advancement Device (Somnomed Flex)DEVICE

The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature

Also known as: Somnomed Flex
Mandibular Advancement Device

Eligibility Criteria

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

You may qualify if:

  • AHI \> 15 events/hour
  • Willing to participate after informed consent
  • Positive advice on OAT after DISE

You may not qualify if:

  • Insufficient teeth to support the device
  • Periodontal problems including tooth mobility
  • Active temporomandibular joint dysfunction
  • Limited maximum protrusive capacity (\< 6 mm)

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, Vanderveken OM, Shivalkar B, Van Haesendonck G, Kastoer C, Heidbuchel H, Braem MJ, Van De Heyning CM. Mandibular advancement device treatment and reverse left ventricular hypertrophic remodeling in patients with obstructive sleep apnea. J Clin Sleep Med. 2022 Mar 1;18(3):903-909. doi: 10.5664/jcsm.9766.

    PMID: 34728052DERIVED

MeSH Terms

Interventions

Occlusal Splints

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Olivier Vanderveken, MD, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ethisch Comité UZ Antwerpen

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 19, 2014

Study Start

December 1, 2014

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

BE(1)